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Wed, Nov 11, 2009		3rd Annual Stability Testing Conference - Conference (BSG House, London, UK) Well planned, executed and managed stability studies are critical for understanding data generated during clinical trials. Stability testing is an expensive part of product development, but conducted efficiently, it can save money in latter parts of the lifecycle. Visiongain's 3rd Annual Stability Testing conference will examine developments in technology for stability assessment. As part of this 2-day event, leading authorities will assess the application and limitations of various analytical and statistical methods, as well as study design. Participants will be provided with a reliable evaluation of the principles and techniques associated with the stability testing of biologics and new pharmaceutical products.
Thu, Nov 12, 2009		3rd Annual Stability Testing Conference - Conference (BSG House, London, UK) Well planned, executed and managed stability studies are critical for understanding data generated during clinical trials. Stability testing is an expensive part of product development, but conducted efficiently, it can save money in latter parts of the lifecycle. Visiongain's 3rd Annual Stability Testing conference will examine developments in technology for stability assessment. As part of this 2-day event, leading authorities will assess the application and limitations of various analytical and statistical methods, as well as study design. Participants will be provided with a reliable evaluation of the principles and techniques associated with the stability testing of biologics and new pharmaceutical products.
Mon, Nov 16, 2009		Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
Tue, Nov 17, 2009		Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
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		Good Clinical Practices (GCPs) - Course / Training / Workshop (Malvern, PA)
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.
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 9:00am		One Medicine: Comparative Aspects of Research and Clinical Diagnosis in Allergic Disease - Conference (BioPark Hertfordshire, Welwyn Garden City)
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.
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)
Tue, Dec 1, 2009		Clinical Trials Design for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Wed, Dec 2, 2009		Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
Thu, Dec 3, 2009		Best Practice in Phase IV Clinical & Observational Research - Conference (Prague, Czech Republic)
Thu, Dec 3, 2009		Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
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		Best Practice in Phase IV Clinical & Observational Research - Conference (Prague, Czech Republic)
Fri, Dec 4, 2009		Essentials of Clinical Study Management - Course / Training / Workshop (Ramada Plaza Basel, Basel, Switzerland)
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
Tue, Dec 8, 2009		ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES - Seminar (The Rembrandt Hotel, London, SW7) BENEFIITS IN ATTENDING: Understand the Significance of the Revision of the MDD In Relation to Adverse Incident Reporting Gain an Overview of the Current System In Europe Keep Abreast with GHTF Progress Know the Role of the Data Safety Monitoring Board Understand the Definitions and Classification of Adverse Events Get an Insight into Competent Authorities Expectations Learn What Happens After CE Marking COURSE OBJECTIVES At the end of the course delegates will be able to:- Explain the regulations governing the monitoring and reporting of adverse events Produce an appropriate adverse event form for use during a study Define and classify adverse events occurring during a study Understand the changes in the regulations and how they impact onadverse event reporting WHO SHOULD ATTEND Those responsible for monitoring medical device clinical studies and those involved in adverse event management and reporting in house and in the field, including; clinical and regulatory staff. Clinical Investigators and clinical site staff who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reportingadverse events during the conduct of a device study. With: Janette Benaddi, Chief Executive Officer, Medvance Ltd.
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
Fri, Dec 11, 2009		HOW TO AUDIT REGULATORY AFFAIRS & CLINICAL TRIALS - Seminar (The Rembrandt Hotel, London) Discount Available if booked with DOCUMENT MANAGEMENT AND ARCHIVING FOR CLINICAL RESEARCH AND REGULATORY AFFAIRS COMPLIANCE - A12-4309 - 10 December 2009 Overview GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. This intensive course provides a comprehensive overview of how to carry out GCP audits for regulatory affairs and clinical research activities. It has been specifically designed to develop audit skills in the EU. It will also help ensure that in your audit role you will understand how the audit programme is essential in achieving regulatory GCP compliance. Participants will review the steps involved in preparing for and carrying out GCP audits for Regulatory Affairs and Clinical Trials, including audit checklists and EMEA inspection guidelines for different type of audits, writing the audit report and developing corrective action plans.
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		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 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.
Wed, Jan 27, 2010		THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role - Conference (The Rembrandt Hotel, London) This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include: Planning and preparation for setting up clinical trials, Understanding the responsibilities at both the study site and the sponsor site, How to carry out the crucial study site visits including, How to prepare for an audit and/or regulatory inspection, Technological advances on collecting data - EDC, On finishing the course you will then be up to date on the latest regulatory GCP requirements including the EU Clinical Trial Directive and Implementation texts, and the GCP Directive.
Thu, Jan 28, 2010		THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role - Conference (The Rembrandt Hotel, London) This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include: Planning and preparation for setting up clinical trials, Understanding the responsibilities at both the study site and the sponsor site, How to carry out the crucial study site visits including, How to prepare for an audit and/or regulatory inspection, Technological advances on collecting data - EDC, On finishing the course you will then be up to date on the latest regulatory GCP requirements including the EU Clinical Trial Directive and Implementation texts, and the GCP Directive.
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
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
Tue, Mar 16, 2010		Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore) Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Wed, Mar 17, 2010		Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore) Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Thu, Mar 18, 2010		Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore) Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Fri, Mar 19, 2010		Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore) Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Mon, Jun 7, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Tue, Jun 8, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.

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