DIA Europe 2023

PrimeVigilance looks forward to attending the upcoming European Pharmacovigilance Congress 2024 that will take place Online between 18-19 November and Face-to-Face in Milan on 22 November.

As leaders in the field of pharmacovigilance, regulatory affairs, and quality assurance, the team will actively engage with attendees, sharing insights on the latest industry developments and fostering discussions on quality, compliance, and best practices in the rapidly evolving regulatory landscape.

PrimeVigilance Expert Sessions

𝗜𝗡𝗧𝗘𝗥𝗔𝗖𝗧𝗜𝗩𝗘 𝗙𝟮𝗙 𝗪𝗢𝗥𝗞𝗦𝗛𝗢𝗣: 22 November | 11.10-12:30 | Milan

Speaker:
Mercedina del Papa
Strategic Advisor II

Topic I: “𝗧𝗵𝗲 𝗟𝗮𝘁𝗲𝘀𝘁 𝗿𝗲𝘃𝗶𝘀𝗶𝗼𝗻𝘀 𝗼𝗳 𝗚𝗩𝗣 𝗴𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 𝗼𝗻 𝗥𝗶𝘀𝗸 𝗠𝗶𝗻𝗶𝗺𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗠𝗲𝗮𝘀𝘂𝗿𝗲𝘀 𝗮𝗻𝗱 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 – 𝗹𝗲𝘁❜𝘀 𝗻𝗮𝘃𝗶𝗴𝗮𝘁𝗲 𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝘁𝗵𝗲 𝘂𝗽𝗱𝗮𝘁𝗲𝘀”

This webinar will focus on the recent revision of GVP Module XVI, which impacts Marketing Authorisation Holders and Applicants. A review of the role of risk minimisation in risk management planning, the effect on the risk-benefit balance of medicinal products, and the importance of evaluating the effectiveness of risk minimization measures.

Speaker:
Natalia Kocankova
Senior Strategic Advisor

Topic II: “𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗠𝗔 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 – 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗳𝗼𝗿 𝘀𝗽𝗼𝗻𝘀𝗼𝗿𝘀 𝘁𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺𝗶𝗻𝗴 𝘁𝗼 𝗠𝗔𝗛”

This webinar will navigate your pharmacovigilance steps on the road map between Marketing application and Marketing Approval from the MAH perspective focusing on Pharmacovigilance system compliance and availability of the products for patients before the EU approval.