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Post marketing responsibilities for pharmacovigilance in the European Union (EU)
The webinar will cover the roles of the responsibilities of marketing authorization holders with respect to marketing products in the EU:
- The legislation covering marketed products in the EU
- The requirement for a pharmacovigilance system and what that entails
- Case processing, periodic reporting, signal detection, risk management, labelling, audit and inspection
- The requirement for a Pharmacovigilance system master file
- The requirement for an EU Qualified person for pharmacovigilance
Overview of the webinar
There is comprehensive regulation around the safety of medicines in the EU and marketing authorization holders have extensive responsibilities in this area for the drugs they market.
The presentation will provide information on the requirements for pharmacovigilance of marketed products in the EU with detail provided on the processes and activities required to meet those requirements.
Who should attend?
- Pharmacovigilance Scientists/ Managers
- Clinical Research Scientists/ Managers
- Regulatory Affairs Professionals
Why should you attend?
There is comprehensive regulation in the EU around the safety of medicines and marketing authorization holders have extensive responsibilities in this area for the medicines they are developing and selling. The presentation will cover the key responsibilities companies haven within the EU once a product is licensed and show what companies need to do to remain compliant in this area.
Faculty - Ms.Janet Jepras
Jan Jepras is a pharmacovigilance consultant with over 20 years experience of drug safety across all phases of drug development. Jan was a Pharmacovigilance Manager at GSK between 1999 and 2010 and has been an independent consultant since then working with a variety of clients both big and small. Jan is experienced in all aspects of pharmacovigilance but specialises in pharmacovigilance writing such as global drug registration submissions, risk management plans, periodic reporting, signal detection and evaluation and training. Jan is a Fellow of The Pharmaceutical Information and Pharmacovigilance Association and lectures on Pharmacovigilance on the MSc course in Pharmaceutical Medicine at the University of Surrey.