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Thu, Nov 26, 2009

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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		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		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.
Mon, Jan 4, 2010		cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop
Tue, Jan 5, 2010		cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop
Wed, Jan 6, 2010		cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop
Thu, Jan 7, 2010		How to Implement Risk Management Principles and Activities within a Quality Management System - Course / Training / Workshop (Malvern, PA)
Thu, Jan 7, 2010		Auditing and Qualifying Suppliers and Vendors - Course / Training / Workshop (Malvern, PA)
Thu, Jan 7, 2010		Good Monitoring Practices for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Fri, Jan 8, 2010		How to Implement Risk Management Principles and Activities within a Quality Management System - Course / Training / Workshop (Malvern, PA)
Fri, Jan 8, 2010		Auditing and Qualifying Suppliers and Vendors - Course / Training / Workshop (Malvern, PA)
Fri, Jan 8, 2010		Good Monitoring Practices for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Mon, Jan 11, 2010		Best Practices for an Effective Cleaning Validation Program - Course / Training / Workshop
Mon, Jan 11, 2010		ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development - Course / Training / Workshop (Malvern, PA)
Mon, Jan 11, 2010		Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Mon, Jan 11, 2010		Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Malvern, PA)
Tue, Jan 12, 2010		Best Practices for an Effective Cleaning Validation Program - Course / Training / Workshop
Tue, Jan 12, 2010		ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development - Course / Training / Workshop (Malvern, PA)
Tue, Jan 12, 2010		Latin America - Understanding Regulatory Compliance Requirements - Course / Training / Workshop (Malvern, PA)
Tue, Jan 12, 2010		Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Malvern, PA)
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)?
Wed, Jan 13, 2010		ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development - Course / Training / Workshop (Malvern, PA)
Wed, Jan 13, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Malvern, PA)
Wed, Jan 13, 2010		Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Course / Training / Workshop (Costa Mesa, CA)
Wed, Jan 13, 2010		Process Validation for Drugs and Biologics - Course / Training / Workshop (Malvern, PA)
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)?
Thu, Jan 14, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Malvern, PA)
Thu, Jan 14, 2010		Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Course / Training / Workshop (Costa Mesa, CA)
Thu, Jan 14, 2010		Process Validation for Drugs and Biologics - Course / Training / Workshop (Malvern, PA)
Fri, Jan 15, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Malvern, PA)
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
Wed, Jan 20, 2010		Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
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
Thu, Jan 21, 2010		Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
Thu, Jan 21, 2010		Detecting Fraud and Misconduct in Clinical Trials - Course / Training / Workshop (Costa Mesa, CA)
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.
Fri, Jan 22, 2010		Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
Fri, Jan 22, 2010		Detecting Fraud and Misconduct in Clinical Trials - Course / Training / Workshop (Costa Mesa, CA)
Mon, Jan 25, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Costa Mesa, CA)
Mon, Jan 25, 2010		Good Laboratory Practices (GLP) for Pre-Clinical Testing - Course / Training / Workshop (Malvern, PA)
Mon, Jan 25, 2010		Validation of Computer Systems - Course / Training / Workshop (Malvern, PA)
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
Tue, Jan 26, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Costa Mesa, CA)
Tue, Jan 26, 2010		Good Laboratory Practices (GLP) for Pre-Clinical Testing - Course / Training / Workshop (Malvern, PA)
Tue, Jan 26, 2010		Validation of Computer Systems - Course / Training / Workshop (Malvern, PA)
Wed, Jan 27, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Costa Mesa, CA)
Wed, Jan 27, 2010		Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
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
Thu, Jan 28, 2010		Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
Thu, Jan 28, 2010		How to Monitor Clinical Trials for GCP Compliance - Course / Training / Workshop (Costa Mesa, CA)
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
Fri, Jan 29, 2010		Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
Fri, Jan 29, 2010		How to Monitor Clinical Trials for GCP Compliance - Course / Training / Workshop (Costa Mesa, CA)
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
Mon, Feb 1, 2010		Introduction to Effective Medical Writing - Course / Training / Workshop (Malvern, PA)
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
Tue, Feb 2, 2010		Introduction to Effective Medical Writing - Course / Training / Workshop (Malvern, PA)
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
Wed, Feb 3, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Malvern, PA)
Wed, Feb 3, 2010		Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries - Course / Training / Workshop (Malvern, PA)
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.
Thu, Feb 4, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Malvern, PA)
Thu, Feb 4, 2010		Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries - Course / Training / Workshop (Malvern, PA)
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.
Fri, Feb 5, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Malvern, PA)
Mon, Feb 8, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Malvern, PA)
Mon, Feb 8, 2010		Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products - Course / Training / Workshop (Malvern, PA)
Mon, Feb 8, 2010		FDA Inspections of Clinical Data Systems - Course / Training / Workshop (Malvern, PA)
Mon, Feb 8, 2010		Practical Methods for Project Management - Course / Training / Workshop (Costa Mesa, CA)
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
Tue, Feb 9, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Malvern, PA)
Tue, Feb 9, 2010		Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products - Course / Training / Workshop (Malvern, PA)
Tue, Feb 9, 2010		FDA Inspections of Clinical Data Systems - Course / Training / Workshop (Malvern, PA)
Tue, Feb 9, 2010		Practical Methods for Project Management - Course / Training / Workshop (Costa Mesa, CA)
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, Feb 10, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Malvern, PA)
Wed, Feb 10, 2010		QA/QC Strategy for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Thu, Feb 11, 2010		QA/QC Strategy for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Thu, Feb 11, 2010		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Fri, Feb 12, 2010		QA/QC Strategy for Biopharmaceuticals and Biologics - Course / Training / Workshop (Malvern, PA)
Fri, Feb 12, 2010		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Thu, Feb 18, 2010		Effective Laboratory Safety Management - Course / Training / Workshop (Costa Mesa, CA)
Fri, Feb 19, 2010		Effective Laboratory Safety Management - Course / Training / Workshop (Costa Mesa, CA)
Mon, Feb 22, 2010		Writing Effective Standard Operating Procedures and Other Process Documents - Course / Training / Workshop (Malvern, PA)
Mon, Feb 22, 2010		FDA Inspections - What to Expect and How to Prepare - Course / Training / Workshop (Malvern, PA)
Mon, Feb 22, 2010		Cost Contained Regulatory Compliance for the Drug, Biologics and Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Tue, Feb 23, 2010		Writing Effective Standard Operating Procedures and Other Process Documents - Course / Training / Workshop (Malvern, PA)
Tue, Feb 23, 2010		FDA Inspections - What to Expect and How to Prepare - Course / Training / Workshop (Malvern, PA)
Tue, Feb 23, 2010		Cost Contained Regulatory Compliance for the Drug, Biologics and Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Wed, Feb 24, 2010		Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Wed, Feb 24, 2010		Writing in the Regulated Environment When English Is Your Second Language - Course / Training / Workshop (Malvern, PA)
Wed, Feb 24, 2010		Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010		Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010		Writing in the Regulated Environment When English Is Your Second Language - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010		Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 1, 2010		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Berlin, Germany)
Mon, Mar 1, 2010		Good Clinical Practice for Medical Device Investigations - Course / Training / Workshop (Malvern, PA)
Mon, Mar 1, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Berlin, Germany)
Tue, Mar 2, 2010		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Berlin, Germany)
Tue, Mar 2, 2010		Good Clinical Practice for Medical Device Investigations - Course / Training / Workshop (Malvern, PA)
Tue, Mar 2, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Berlin, Germany)
Tue, Mar 2, 2010		Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Wed, Mar 3, 2010		Biostatistics for Non-Statisticians - Course / Training / Workshop (Berlin, Germany)
Wed, Mar 3, 2010		Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Wed, Mar 3, 2010		Good Clinical Practice Auditing - Course / Training / Workshop (Malvern, PA)
Wed, Mar 3, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Berlin, Germany)
Thu, Mar 4, 2010		Good Clinical Practice Auditing - Course / Training / Workshop (Malvern, PA)
Thu, Mar 4, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Berlin, Germany)
Fri, Mar 5, 2010		The Drug Development Process - From Discovery to Commercialization - Course / Training / Workshop (Berlin, Germany)
Mon, Mar 8, 2010		Introduction to Molecular Biology Techniques - Course / Training / Workshop (Malvern, PA)
Mon, Mar 8, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Berlin, Germany)
Mon, Mar 8, 2010		Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010		Introduction to Molecular Biology Techniques - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Berlin, Germany)
Tue, Mar 9, 2010		Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010		The EU Clinical Trial Directive - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010		How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach - Course / Training / Workshop (Malvern, PA)
Wed, Mar 10, 2010		Good Clinical Practices (GCP) - Course / Training / Workshop (Berlin, Germany)
Wed, Mar 10, 2010		The EU Clinical Trial Directive - Course / Training / Workshop (Malvern, PA)
Wed, Mar 10, 2010		How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach - Course / Training / Workshop (Malvern, PA)
Wed, Mar 10, 2010		The CTD/eCTD: Building the Marketing Application throughout Clinical Development - Course / Training / Workshop (Malvern, PA)
Thu, Mar 11, 2010		The CTD/eCTD: Building the Marketing Application throughout Clinical Development - Course / Training / Workshop (Malvern, PA)
Thu, Mar 11, 2010		Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business - Course / Training / Workshop (Malvern, PA)
Thu, Mar 11, 2010		How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices - Course / Training / Workshop (Malvern, PA)
Thu, Mar 11, 2010		European Filing & Registration Procedures - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010		The CTD/eCTD: Building the Marketing Application throughout Clinical Development - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010		Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010		How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010		European Filing & Registration Procedures - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010		Preparing the CMC Section for NDAs/CTDs/INDs - Course / Training / Workshop (Costa Mesa, CA)
Mon, Mar 15, 2010		Cleanroom Microbiology for the Non-Microbiologist - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010		Labeling and Labeling Controls for Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010		Clinical Trials Design for Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010		Validation of Computer Systems - Course / Training / Workshop (Berlin, Germany)
Tue, Mar 16, 2010		Preparing the CMC Section for NDAs/CTDs/INDs - Course / Training / Workshop (Costa Mesa, CA)
Tue, Mar 16, 2010		Cleanroom Microbiology for the Non-Microbiologist - Course / Training / Workshop (Malvern, PA)
Tue, Mar 16, 2010		Labeling and Labeling Controls for Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Mar 16, 2010		Clinical Trials Design for Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Mar 16, 2010		Validation of Computer Systems - Course / Training / Workshop (Berlin, Germany)
Wed, Mar 17, 2010		Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Wed, Mar 17, 2010		Sterilization Procedures: Technology, Equipment & Validation - Course / Training / Workshop (Malvern, PA)
Wed, Mar 17, 2010		Purchasing Controls in the Medical Device Industry - Course / Training / Workshop (Malvern, PA)
Thu, Mar 18, 2010		Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Thu, Mar 18, 2010		Sterilization Procedures: Technology, Equipment & Validation - Course / Training / Workshop (Malvern, PA)
Thu, Mar 18, 2010		Purchasing Controls in the Medical Device Industry - Course / Training / Workshop (Malvern, PA)
Fri, Mar 19, 2010		Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Mon, Mar 22, 2010		Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)
Mon, Mar 22, 2010		Project Management for Phase 1 & 2 Clinical Trials - Course / Training / Workshop (Malvern, PA)
Mon, Mar 22, 2010		Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products - Course / Training / Workshop (Costa Mesa, CA)
Mon, Mar 22, 2010		Pharmaceutical Production Batch Record Review - Course / Training / Workshop (Costa Mesa, CA)
Tue, Mar 23, 2010		Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)
Tue, Mar 23, 2010		Project Management for Phase 1 & 2 Clinical Trials - Course / Training / Workshop (Malvern, PA)
Tue, Mar 23, 2010		Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products - Course / Training / Workshop (Costa Mesa, CA)
Tue, Mar 23, 2010		Pharmaceutical Production Batch Record Review - Course / Training / Workshop (Costa Mesa, CA)
Wed, Mar 24, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Dublin, Ireland)
Wed, Mar 24, 2010		Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies - Course / Training / Workshop (Costa Mesa, CA)
Wed, Mar 24, 2010		Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process - Course / Training / Workshop (Malvern, PA)
Thu, Mar 25, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Dublin, Ireland)
Thu, Mar 25, 2010		Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies - Course / Training / Workshop (Costa Mesa, CA)
Thu, Mar 25, 2010		Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process - Course / Training / Workshop (Malvern, PA)
Fri, Mar 26, 2010		Root Cause Analysis for CAPA - Course / Training / Workshop (Dublin, Ireland)
Fri, Mar 26, 2010		Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies - Course / Training / Workshop (Costa Mesa, CA)
Mon, Mar 29, 2010		Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Dublin, Ireland)
Mon, Mar 29, 2010		Selecting and Managing CRO's - Course / Training / Workshop (Malvern, PA)
Tue, Mar 30, 2010		Selecting and Managing CRO's - Course / Training / Workshop (Malvern, PA)
Wed, Mar 31, 2010		Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
Thu, Apr 1, 2010		Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
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.

Nothing in this website should be used in place of personal medical advice from your own qualified medical practitioner.