Registration for a Webinar
The EU Good Pharmacovigilance Practice (GVP) Module XVI (and related Addendum specifically covering Educational Materials) provides detailed guidance and requirements for developing Educational Materials and evaluating their effectiveness. Once the Educational Materials are defined and approved along with the RMP, the MAH must implement them individually in each member state. Each of the Member States has its local requirements, which can sometimes result in unexpected issues during the implementation, and consequently delay the product’s launch.
We aim to delve deeper into the national implementation of Educational Materials by providing nuances and specifics in different countries, consolidating best practices and approach on how to solve challenges, or at least to minimise impact of them on implementation at local level.
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Presenter: Lauryna Gaižutienė is experienced and goal-oriented professional with 7 years of experience in pharmacovigilance field. Experience ranging from literature screening, ICSR collection and analysis, regulatory intelligence, risk management activities, development and overview of SOPs, project management from the set-up phase and further successful workflow. Continuously participating in audits (internal, external), deviation / CAPA implementation. Currently responsible for the management and oversight of local pharmacovigilance activities, processes – leading the Team to achieve success together.
Agenda:
- Country Specifics
- Differences
- Challenges
- Best Practices & Examples
- Q&A
Language: English
Open to: everyone who has registered
Duration: up to 45 mins.
The webinar is free of charge.