REKS (Estonian Medicines verification Organisation) organised a virtual event “The FMD and Regulatory Affairs Symposium” which took place on 2 October 2020 10:00-14:00 (EET).

The webinar was jointly held by APME (the Association of Pharmaceutical Manufacturers in Estonia).

The event brought together Regulatory Affairs field specialists from Estonia, Latvia and Lithuania as well as others including stakeholders, 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 live stream and the full program. The meeting was also be streamed on REKS’ 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 Organisations (EMVO) PDF
3. “PIF and RA community, Nordic experiences 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 Baltics 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” – Francois Lamérant, Senior Manager Economics & 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