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5217 Compliance to Clinical Safety and Pharmacovigilance Regulations
Instructor:
» Dr. Fabio Trave
Next course:
June 4-5 2009, Prague, Czech rep.
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-17.00 Registration 08.00-08.30
Day 2: 8.30-17.00
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
» Dr. Fabio Trave
Next course:
June 4-5 2009, Prague, Czech rep.
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-17.00 Registration 08.00-08.30
Day 2: 8.30-17.00
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Industry field:
Pharmaceutical industry
Course description:
The objective of this introductory course on compliance to drug safety and pharmacovigilance regulations is to critically review and interpret current rules and guidelines pertinent to drug safety and pharmacovigilance and to understand and properly prepare for pharmacovigilance regulatory inspections.
Focus will be on the European environment.
Systems and processes pertinent to pharmacovigilance in the broader sense - from individual case report submission to risk assessment, characterization, communication and minimization - and implemented at all stages during a medicinal product's life cycle will be reviewed and discussed in light of the interpretation of current regulations and guidelines.
Course outline:
Current regulations, processes and documents pertinent to drug safety and pharmacovigilance:
• Introduction and course presentation.
• Body of legislations and guidelines concerning drug safety reporting and pharmacovigilance.
• EudraLex Volume 9A: how to read it and what to remember.
• Clinical safety and the Clinical Trial Directive 2001/20/EC: issues.
• Pharmacovigilance planning and risk management strategy in Europe.
• Company reference documents relevant to drug safety: content, responsability/accountability, alignment, updating.
• Discussions and questions.
Towards pharmacovigilance regulatory inspections:
• Regulatory Authorities in Europe and their interaction with the pharmaceutical industry.
• The Qualified Person for Pharmacovigilance and the Summary of Pharmacovigilance Systems.
• How to prepare for a pharmacovigilance regulatory inspection: rules, expectations and common mistakes.
• Break-out session.
• The Safety Data Exchange Agreements.
• Discussions and questions.
• End-of-course questionnaire
Learning objectives:
Attendees will gain or reinforce knowledge of current drug safety and pharmacovigilance rules and processes, as well as regulatory trends and expectations. They will learn practical skills for addressing methodological issues in pharmacovigilance, contributing to optimize company procedures and processes concerning pharmacovigilance, and properly undergoing regulatory inspections conduced within Europe. This course is presented by a former EU Qualified Person for Pharmacovigilance.
Who should attend:
The course is intended for professionals working in pharmaceutical companies or contract research organizations who are involved in clinical research, regulatory affairs, medical affairs and safety surveillance.
Pharmaceutical industry
Course description:
The objective of this introductory course on compliance to drug safety and pharmacovigilance regulations is to critically review and interpret current rules and guidelines pertinent to drug safety and pharmacovigilance and to understand and properly prepare for pharmacovigilance regulatory inspections.
Focus will be on the European environment.
Systems and processes pertinent to pharmacovigilance in the broader sense - from individual case report submission to risk assessment, characterization, communication and minimization - and implemented at all stages during a medicinal product's life cycle will be reviewed and discussed in light of the interpretation of current regulations and guidelines.
Course outline:
Current regulations, processes and documents pertinent to drug safety and pharmacovigilance:
• Introduction and course presentation.
• Body of legislations and guidelines concerning drug safety reporting and pharmacovigilance.
• EudraLex Volume 9A: how to read it and what to remember.
• Clinical safety and the Clinical Trial Directive 2001/20/EC: issues.
• Pharmacovigilance planning and risk management strategy in Europe.
• Company reference documents relevant to drug safety: content, responsability/accountability, alignment, updating.
• Discussions and questions.
Towards pharmacovigilance regulatory inspections:
• Regulatory Authorities in Europe and their interaction with the pharmaceutical industry.
• The Qualified Person for Pharmacovigilance and the Summary of Pharmacovigilance Systems.
• How to prepare for a pharmacovigilance regulatory inspection: rules, expectations and common mistakes.
• Break-out session.
• The Safety Data Exchange Agreements.
• Discussions and questions.
• End-of-course questionnaire
Learning objectives:
Attendees will gain or reinforce knowledge of current drug safety and pharmacovigilance rules and processes, as well as regulatory trends and expectations. They will learn practical skills for addressing methodological issues in pharmacovigilance, contributing to optimize company procedures and processes concerning pharmacovigilance, and properly undergoing regulatory inspections conduced within Europe. This course is presented by a former EU Qualified Person for Pharmacovigilance.
Who should attend:
The course is intended for professionals working in pharmaceutical companies or contract research organizations who are involved in clinical research, regulatory affairs, medical affairs and safety surveillance.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com