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Nov 2009
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Sun, Nov 8, 2009


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Mon, Nov 9, 2009
 How to Implement Risk Management Principles and Activities Within a Quality Management System - Course / Training / Workshop (Dublin, Ireland)
Mon, Nov 9, 2009
 Cleanroom Microbiology for the Non-Microbiologist - Course / Training / Workshop (Malvern, PA)
Mon, Nov 9, 2009
 Writing Effective Standard Operating Procedures and Other Process Documents - Course / Training / Workshop (Costa Mesa, CA)
Mon, Nov 9, 2009
 Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Tue, Nov 10, 2009
 How to Implement Risk Management Principles and Activities Within a Quality Management System - Course / Training / Workshop (Dublin, Ireland)
Tue, Nov 10, 2009
 Cleanroom Microbiology for the Non-Microbiologist - Course / Training / Workshop (Malvern, PA)
Tue, Nov 10, 2009
 Writing Effective Standard Operating Procedures and Other Process Documents - Course / Training / Workshop (Costa Mesa, CA)
Tue, Nov 10, 2009
 Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Tue, Nov 10, 2009
 Principles of Organic Chemistry - Course / Training / Workshop (Malvern, PA)
Wed, Nov 11, 2009
 Pre-Conference Seminar QbD IN INHALATION PRODUCT DEVELOPMENT - Course / Training / Workshop (The Cavendish Hotel, London)
Full Details will follow shortly. Please contact andrea.james@management-forum.co.uk for further information or a brochure.
Wed, Nov 11, 2009
 Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Wed, Nov 11, 2009
 Principles of Organic Chemistry - Course / Training / Workshop (Malvern, PA)
Wed, Nov 11, 2009
 Sterilization Procedures: Technology, Equipment and Validation - Course / Training / Workshop (Malvern, PA)
Wed, Nov 11, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Dublin, Ireland)
Wed, Nov 11, 2009
 PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Thu, Nov 12, 2009
 INHALED DRUG DELIVERY (IDD) - Course / Training / Workshop (Le Meridien Piccadilly, London)
Thu, Nov 12, 2009
 Sterilization Procedures: Technology, Equipment and Validation - Course / Training / Workshop (Malvern, PA)
Thu, Nov 12, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Dublin, Ireland)
Thu, Nov 12, 2009
 Preparing the CMC Section for NDAs/INDs/CTDs - Course / Training / Workshop (King of Prussia, PA)
Thu, Nov 12, 2009
 Writing in the Regulated Environment When English Is Your Second Language - Course / Training / Workshop (Costa Mesa, CA)
Thu, Nov 12, 2009
 Principles of Analytical Chemistry - Course / Training / Workshop (Malvern, PA)
Thu, Nov 12, 2009
 PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Fri, Nov 13, 2009
 INHALED DRUG DELIVERY (IDD) - Course / Training / Workshop (Le Meridien Piccadilly, London)
Fri, Nov 13, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Dublin, Ireland)
Fri, Nov 13, 2009
 Preparing the CMC Section for NDAs/INDs/CTDs - Course / Training / Workshop (King of Prussia, PA)
Fri, Nov 13, 2009
 Writing in the Regulated Environment When English Is Your Second Language - Course / Training / Workshop (Costa Mesa, CA)
Fri, Nov 13, 2009
 Principles of Analytical Chemistry - Course / Training / Workshop (Malvern, PA)
Mon, Nov 16, 2009
 GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Lands End, Mumbai, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Mon, Nov 16, 2009
 Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
Mon, Nov 16, 2009
 SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London)
This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Tue, Nov 17, 2009
 Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
Tue, Nov 17, 2009
 Pharmaceutical Water Systems - Contemporary Technology & Compliance - Course / Training / Workshop (Malvern, PA)
Tue, Nov 17, 2009
 SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London)
This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Tue, Nov 17, 2009
 LATEST DEVELOPMENTS IN PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London)
If you work in Drug Safety, this advanced course has been specifically designed to provide you with an update on the latest developments impacting on your role. The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to Pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and you will also be welcome to contribute your own experiences.
Wed, Nov 18, 2009
 Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Wed, Nov 18, 2009
 GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Palace, New Delhi, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Wed, Nov 18, 2009
 Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
Wed, Nov 18, 2009
 Pharmaceutical Water Systems - Contemporary Technology & Compliance - Course / Training / Workshop (Malvern, PA)
Wed, Nov 18, 2009
 Root Cause Analysis for CAPA - Course / Training / Workshop (King of Prussia, PA)
Wed, Nov 18, 2009
 LATEST DEVELOPMENTS IN PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London)
If you work in Drug Safety, this advanced course has been specifically designed to provide you with an update on the latest developments impacting on your role. The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to Pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and you will also be welcome to contribute your own experiences.
Wed, Nov 18, 2009
9:00am		 REGULATORY BASICS by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110)
This course is designed for pharmaceutical and biotech professionals responsible for regulatory strategy and operations. It will teach the essentials of regulatory project management, with a focus on how these skills can be applied in the process of creating an initial Investigational New Drug (IND) application. Through the use of lectures, discussions and case studies, participants will learn about the key elements of the regulatory process in the United States, discuss the required elements of an IND, the utility of the Clinical Trials Directive (CTD) for building a foundation for continued development and other key topics. Who will benefit: This course will be beneficial to those new to regulatory affairs as well as those with regulatory experience but limited exposure to the early phases of development stage work in the pharmaceutical and biotech industries. Managers who are not versed in regulatory, but are involved with clinical trial programs will also benefit. Key topics: * What is an IND? * The Pre-IND Meeting - Dos and Don'ts * What is FDA looking for in the initial application * Is the CTD an option? * Timeline management * Submission and post submission success Learning Outcomes: * Understanding of the IND process and key decision points * Understanding of how regulatory strategy drives decisions in the drug development process * Recognition of regulatory hurdles * Knowledge of how to build effective submissions * Recognition of the need to effectively manage expectations and timelines For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Thu, Nov 19, 2009
 Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Thu, Nov 19, 2009
 European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Thu, Nov 19, 2009
 Root Cause Analysis for CAPA - Course / Training / Workshop (King of Prussia, PA)
Thu, Nov 19, 2009
 Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Thu, Nov 19, 2009
 Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products - Course / Training / Workshop (Malvern, PA)
Fri, Nov 20, 2009
 Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Fri, Nov 20, 2009
 European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009
 GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Krishna, Hyderabad, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Fri, Nov 20, 2009
 Root Cause Analysis for CAPA - Course / Training / Workshop (King of Prussia, PA)
Fri, Nov 20, 2009
 Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Fri, Nov 20, 2009
 Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products - Course / Training / Workshop (Malvern, PA)
Mon, Nov 23, 2009
 Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal)
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Tue, Nov 24, 2009
 Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal)
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Tue, Nov 24, 2009
 SUPPLIER QUALITY MANAGEMENT - How well do you know your Suppliers and Supply Chain? - Course / Training / Workshop (The Rembrandt Hotel, London)
Topics to be Covered: Cost Effectiveness: The current trend is to source raw materials and APIs from outside Europe and the US, Supplies are more often sourced from India and China. Significant Challenges: Identification, Assessment, Approval, Management of the Supply Chain. The Regulatory Authorities: Close attention to how you manage your Supply Chain. The Impact on your Company: The impact of the increased attention from the Regulatory Authorities is felt both on large Pharma companies and smaller Generic manufacturers where the number of product lines present a daunting task if the supply chain is to be effectively managed
Wed, Nov 25, 2009
 Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal)
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Thu, Nov 26, 2009
 Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal)
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Nov 27, 2009
 Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal)
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Nov 27, 2009
 INTRODUCTORY OVERVIEW OF THE PHARMACEUTICAL INDUSTRY - Course / Training / Workshop (The Rembrandt Hotel, London)
Key benefits of attending this meeting:- Increase your understanding of the Pharma Industry, Develop your knowledge of the stages of drug development from drug discovery through to marketing, Understand the roles and responsibilities of key departments and how they work together, Demystify the technical terminology and jargon, Get to grips with the phases of Clinical Trials and regulatory processes.
Mon, Nov 30, 2009
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Mon, Nov 30, 2009
 Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Costa Mesa, CA)
Mon, Nov 30, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Mon, Nov 30, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Tue, Dec 1, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Selecting and Managing CROs - Course / Training / Workshop (Malvern, PA)
Wed, Dec 2, 2009
 Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
Wed, Dec 2, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Wed, Dec 2, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
Wed, Dec 2, 2009
 Selecting and Managing CROs - Course / Training / Workshop (Malvern, PA)
Wed, Dec 2, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Wed, Dec 2, 2009
 CMC Regulatory Compliance for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
Thu, Dec 3, 2009
 RISK MANAGEMENT - Applying it and meeting the Challenges for Industry - Course / Training / Workshop (Harrington Hall Hotel, London)
INTRODUCTION Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability. Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary. A number of standard tools are available for risk management. Which ones should you use and when? ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators? WHO SHOULD ATTEND This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities: ■ Manufacture or QA of API or drug product ■ Manufacturing rationalisation ■ Site transfer for API and / or drug product ■ GMP compliance ■ Management of regulatory QA / manufacturing QA interfaces ■ Design and construction of manufacturing facilities / processes ■ Validation / Cleaning validation ■ Auditing of own company or supplier Personnel from the following backgrounds: ■ Production ■ Quality Assurance ■ Engineering ■ Regulatory Affairs Compliance ■ Project Planners
Thu, Dec 3, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 CMC Regulatory Compliance for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 HOW TO WRITE SOPs - Course / Training / Workshop (The Rembrandt Hotel, London)
Thu, Dec 3, 2009
9:00am		 ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110)
This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Fri, Dec 4, 2009
 Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
Fri, Dec 4, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 CMC Regulatory Compliance for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 CORRECTIVE AND PREVENTATIVE ACTION (CAPA) AND PROCESS IMPROVEMENT - Course / Training / Workshop (The Rembrandt Hotel, London)
Fri, Dec 4, 2009
 THE EU COSMETICS DIRECTIVE AND THE NEW COSMETICS REGULATIONS - Course / Training / Workshop (The Rembrandt Hotel, London)
A quick examination of the cosmetic products sold in many European shops will pick up a significant number of products that do not comply with the EU Cosmetic Regulations. This demonstrates that there are many companies who do not understand the requirements. The EU has recently stated that they wish to enforce labelling requirements more vigorously and there are heavy fines for infringements. It is easy for the authorities to walk round any shop selling cosmetics and look at the labels. Even a minor infringement could lead to a time consuming investigation. Although very complex and lengthy, the regulations are actually quite straightforward if they are summarised, explained properly and put into context. The object of this seminar is to do just this in thorough but simple terms. You will learn what the EU Cosmetics Directive is, how to understand and comply with it.
Fri, Dec 4, 2009
 RISK MANAGEMENT - Applying it and meeting the Challenges for Industry - Course / Training / Workshop (Harrington Hall Hotel, London)
INTRODUCTION Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability. Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary. A number of standard tools are available for risk management. Which ones should you use and when? ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators? WHO SHOULD ATTEND This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities: ■ Manufacture or QA of API or drug product ■ Manufacturing rationalisation ■ Site transfer for API and / or drug product ■ GMP compliance ■ Management of regulatory QA / manufacturing QA interfaces ■ Design and construction of manufacturing facilities / processes ■ Validation / Cleaning validation ■ Auditing of own company or supplier Personnel from the following backgrounds: ■ Production ■ Quality Assurance ■ Engineering ■ Regulatory Affairs Compliance ■ Project Planners
Fri, Dec 4, 2009
9:00am		 ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110)
This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Mon, Dec 7, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Dec 7, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Mon, Dec 7, 2009
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
Wed, Dec 9, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
Wed, Dec 9, 2009
 Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Wed, Dec 9, 2009
 Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Wed, Dec 9, 2009
 EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
Thu, Dec 10, 2009
 DOCUMENT MANAGEMENT & ARCHIVING - Seminar (The Rembrandt Hotel, London)
**Discount Available if booked with HOW TO AUDIT REGULATORY AFFAIRS AND CLINICAL TRIALS - A12-4409 - 11 December 2009** Overview It is essential to document and archive clinical trial documents to ensure compliance with GCP. Clinical Researchers and departments which support clinical trials have to prepare, maintain and archive vast numbers of documents to comply with regulatory requirements for running clinical trials. The audit trail of documents must be transparent and available for regulatory inspection. This compact one day course deals with how to set up, manage and archive clinical trial and regulatory documentation to meet regulatory requirements and prepare for inspection of documentation. An overview of the regulatory background which describes the specific requirements of documentation management and archiving is also covered. This course will be ideal for providing evidence of training in this area to regulatory inspectors
Thu, Dec 10, 2009
 Stem Cells: A Pathway Through the Maze - Oxford University - Course / Training / Workshop (Oxford)
Few topics have captured the imagination of the general public quite as dramatically as stem cells, both for the potential they offer regenerative medicine and the ethical sensitivities they create. This two-day course is intended to dispel the myths behind stem cell biology and introduce delegates to the science behind the headlines, the pitfalls as well as the promises. Although the course will assume basic knowledge of the biomedical sciences, no previous understanding of stem cell biology will be required. The course will begin by introducing key concepts in the field which will form the basis for exploring the properties of selected populations of adult and embryonic stem cells. Day two will be devoted to applied topics that are essential to the therapeutic application of stem cell biology before focussing on ethical and regulatory issues and surveying the landscape for patenting and marketing of stem cell therapies. The taught component of the course will draw on the varied expertise available within the University of Oxford, with contributions from outside experts, where appropriate. This course is led by Dr Paul Fairchild, Sir William Dunn School of Pathology, University of Oxford.
Thu, Dec 10, 2009
 Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Thu, Dec 10, 2009
 Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Course / Training / Workshop (Malvern, PA)
Thu, Dec 10, 2009
 US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London)
FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Fri, Dec 11, 2009
 Stem Cells: A Pathway Through the Maze - Oxford University - Course / Training / Workshop (Oxford)
Few topics have captured the imagination of the general public quite as dramatically as stem cells, both for the potential they offer regenerative medicine and the ethical sensitivities they create. This two-day course is intended to dispel the myths behind stem cell biology and introduce delegates to the science behind the headlines, the pitfalls as well as the promises. Although the course will assume basic knowledge of the biomedical sciences, no previous understanding of stem cell biology will be required. The course will begin by introducing key concepts in the field which will form the basis for exploring the properties of selected populations of adult and embryonic stem cells. Day two will be devoted to applied topics that are essential to the therapeutic application of stem cell biology before focussing on ethical and regulatory issues and surveying the landscape for patenting and marketing of stem cell therapies. The taught component of the course will draw on the varied expertise available within the University of Oxford, with contributions from outside experts, where appropriate. This course is led by Dr Paul Fairchild, Sir William Dunn School of Pathology, University of Oxford.
Fri, Dec 11, 2009
 Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Fri, Dec 11, 2009
 Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Course / Training / Workshop (Malvern, PA)
Fri, Dec 11, 2009
 US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London)
FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Fri, Dec 11, 2009
 RECURRING QUESTIONS IN BIOTECHNOLOGY AND CHEMISTRY CASE LAW OF THE EPO BOARDS OF APPEAL - AN OVERVIEW FOCUSED ON SOME RECENT DECISIONS AND CONTROVERSIAL POINTS - Course / Training / Workshop (The Rembrandt Hotel, London, SW7)
This seminar will provide useful information on European case law in the fields of chemistry and biochemistry, by means of an up to date analysis of decisions of the European Patent Office Boards of Appeal, considering specifically the current topical issues and controversial points. Interaction between speakers and participants will be encouraged throughout the day.
Mon, Dec 14, 2009
 Overview of FDA Regulatory Compliance For Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Dec 14, 2009
 Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Mon, Dec 14, 2009
 PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London)
Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Tue, Dec 15, 2009
 Overview of FDA Regulatory Compliance For Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009
 Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009
 PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London)
Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Wed, Dec 16, 2009
 PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London)
Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Wed, Jan 13, 2010
 PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach - Course / Training / Workshop (Harrington Hall Hotel, London)
"Say what you do and do what you say" - and DOCUMENT IT! This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP. ■ What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment? ■ The framework for a Pharmaceutical Quality System ■ Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP ■ How good are your SOPs (Instructions) and the Evidence of Actions (Records)?
Thu, Jan 14, 2010
 PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach - Course / Training / Workshop (Harrington Hall Hotel, London)
"Say what you do and do what you say" - and DOCUMENT IT! This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP. ■ What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment? ■ The framework for a Pharmaceutical Quality System ■ Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP ■ How good are your SOPs (Instructions) and the Evidence of Actions (Records)?
Mon, Jan 18, 2010
 FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Tue, Jan 19, 2010
 FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Tue, Jan 19, 2010
 CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010 - Course / Training / Workshop (The Rembrandt Hotel, London, SW7)
Tue, Jan 19, 2010
 PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will focus on R&D based pharmaceutical products in Asia and will provide you with: A carefully balanced programme, Up-to-date coverage, All important aspects of gaining and maintaining a successful Marketing Authorisation in Asia, Coverage of underlying official regulatory sources, An interpretation of practical aspects, An overview of the requirements for local manufacturing, Recent Developments, Harmonisation Initiatives, The opportunity to exchange experiences with other delegates
Wed, Jan 20, 2010
 CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010 - Course / Training / Workshop (The Rembrandt Hotel, London, SW7)
Wed, Jan 20, 2010
 PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will focus on R&D based pharmaceutical products in Asia and will provide you with: A carefully balanced programme, Up-to-date coverage, All important aspects of gaining and maintaining a successful Marketing Authorisation in Asia, Coverage of underlying official regulatory sources, An interpretation of practical aspects, An overview of the requirements for local manufacturing, Recent Developments, Harmonisation Initiatives, The opportunity to exchange experiences with other delegates
Wed, Jan 20, 2010
 EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 21, 2010
 EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Fri, Jan 22, 2010
 ACTIVE COMPARATOR STUDIES - Course / Training / Workshop (The Rembrandt Hotel, London)
Active comparator trials can fulfil a number of needs from pivotal marketing approval studies, through label enhancements of an already marketed drug to post-marketing market support. The designs of such studies have their own special issues: superiority vs non-inferiority designs, choice of comparator, two arm or three arm placebo designs amongst many others. This course aims to discuss the theoretical, operational, regulatory and statistical issues involved, using practical examples to encourage interactive discussion to share possible approaches to the design and implementation of active comparator trials. Topics to be covered at this meeting: ■ Purposes of active comparator trials ■ Design for studies ■ Statistical considerations ■ Regulatory documentation & safety monitoring ■ Safety data collection & reporting ■ Post-marketing comparator observational studies WHO SHOULD ATTEND This new course will be of interest to personnel from departments of both pre- and post-marketing pharmacovigilance, research and development, clinical trials, regulatory affairs, project management, and statistics and any others involved in designing development plans involving possible active comparator trials.
Tue, Jan 26, 2010
 COPD & ASTHMA - AN INTRODUCTORY COURSE - Course / Training / Workshop (The Rembrandt Hotel, London, UK)
TOPICS TO BE COVERED: Aetiology, pathophysiology & current management of COPD & Asthma, New Therapies for Asthma & COPD, Clinical Trials in Asthma & COPD, Regulatory aspects of Asthma & COPD Clinical Trials. This one-day course is intended to provide a sound basic knowledge and understanding of the pathopysiology and management of these key respiratory diseases, together with insight into potential new therapies and clinical trial design. This course will be of benefit to all those requiring a basic knowledge of Asthma and COPD including clinical research and regulatory staff of all levels of seniority who are new to the respiratory field.
Tue, Jan 26, 2010
 NEURO LINGUISTIC PROGRAMMING IN THE WORKPLACE - Course / Training / Workshop (Harrington Hall Hotel, London, UK)
What Is NLP? NLP (Neuro-Linguistic Programming) is a huge subject. This one day programme aims to look at introducing some of the fundamental pillars of NLP and to provide a basic insight into this powerful set of tools and to explore how they can be used within the world of work. This seminar will cover a brief overview of Neuro-Linguistic Programming and its history. In this session we will also go through the programme and objectives: Enrich your use of language to inspire,motivate and challenge yourself, clients and colleagues, Enhance your ability to build deep levels of rapport, Learn how to develop well-formed outcomes, Increase your influence overyourself and others through a greater understanding ofmeta-programmes and sorting patterns, Use timelines for developing strategies for accelerating change in yourself and others
Thu, Jan 28, 2010
 MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London)
Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Fri, Jan 29, 2010
 MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London)
Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Mon, Feb 1, 2010
 WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London)
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Tue, Feb 2, 2010
 WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London)
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Wed, Feb 3, 2010
 WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London)
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Thu, Feb 4, 2010
 WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London)
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Thu, Feb 4, 2010
 PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen - Course / Training / Workshop (The Rembrandt Hotel, London)
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, incuding Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
Fri, Feb 5, 2010
 WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London)
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Fri, Feb 5, 2010
 PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen - Course / Training / Workshop (The Rembrandt Hotel, London)
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, incuding Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
Tue, Feb 9, 2010
 THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London)
General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Wed, Feb 10, 2010
 THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London)
General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Wed, Apr 14, 2010
 NASAL DRUG DELIVERY - Course / Training / Workshop (Hote to be Advised, London)
If you are interested in giving a presentation at this event please contact Andrea James on andrea.james@management-forum.co.uk. Exhibition opportunities are also available. Further information will be available soon. Please contact Andrea James on andrea.james@management-forum.co.uk in the meantime should you wish to know more about this conference.
Thu, Apr 15, 2010
 NASAL DRUG DELIVERY - Course / Training / Workshop (Hote to be Advised, London)
If you are interested in giving a presentation at this event please contact Andrea James on andrea.james@management-forum.co.uk. Exhibition opportunities are also available. Further information will be available soon. Please contact Andrea James on andrea.james@management-forum.co.uk in the meantime should you wish to know more about this conference.
Thu, Jul 1, 2010
 EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK)
Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.
Fri, Jul 2, 2010
 EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK)
Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.



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