1. The Baltic Regulatory Affairs (RA) annual meeting “The FMD and Regulatory Affairs Symposium” was virtual this year and took place on 2 October 2020 10:00-14:00 (EET).

    The event was jointly held by APME (the Association of Pharmaceutical Manufacturers in Estonia) and REKS (the Estonian Medicines Verification Organisation).

    The annual meeting brought together RA field specialists from Estonia, Latvia and Lithuania as well as other stakeholders including pharmacists, wholesalers and logistics, to share best practices and key learnings of current hot topics, and also look together into future perspectives.

    The webinar took place at an online platform Worksup. Click HERE to access the recording or watch on APME website.

     PRESENTATIONS

    1. “Alert management in Finland and FiMVO’s experiences”  - Maija Gohlke, General Manager of FiMVO Pdf
    2. “EMVO and the EMVS: Challenges and Future Opportunities” - Fanny Trenteseaux, Project & Partner Manager of European Medicines Verification Organisation (EMVO) Pdf
    3. “PIF and RA community, Nordic experience sharing in artwork and package creation” - Anna Alonen, RA Manager, Medfiles Ltd, representing Pharma Industry Finland (PIF)
    4. “Risk Management Plans - ways of working”  - Helen Shennan, RA Director, AstraZeneca Nordic Baltic MC, representing The Danish Association of the Pharmaceutical Industry (Lif) Pdf
    5. “Dear Doctor Letters and aRMM in RMP – expectations, practice and opportunities from regulator’s perspective”  - Maia Uusküla, Head of Pharmacovigilance department of Estonian State Agency of Medicines Pdf
    6. Multilingual Packaging“ - Margit Plakso, Head of Marketing authorisations department of Estonian State Agency of Medicines Pdf
    7. “Industry recommendations to prevent medicines shortages” - François Lamérant, Senior Manager Economic & Social Affairs of EFPIA Pdf
    8. “Shortages and manufacturing resilience high on the EU pharma policy agenda” - Adrian van den Hoven, Director General of Medicines for Europe Pdf