One year after the entry into force of the ICH R3, which have been the changes, the difficulties and the improvements. These are the topics of the second edition of the European Pharmacovigilance Congress, for which SafetyDrugs will be again the main sponsor.
The congress will take place on 29th and on 30th November 2018 in Milan, at he Ritz Hotel in via Lazzaro Spallanzani 40, in Buenos Aires area.
The first edition, held a few days after the entry into force of the ICH R3 and of the new Eudravigilance database, had focused precisely on those innovations; this second edition will pick up the threads, discussing the problems, the challenges and the most significant changes encountered during the last year.
Among the speakers, the major pharmaceutical companies’ exponents will be present toghether with the best European pharmacovigilance experts, who will deal with issues ranging from the consequences of the new software implementation, to inspections trends and signal detection modalities, up to the general pharmacovigilance process with particular attention to systems of quality and to risk management. A specific intervention will also cover Patient Support Programs (PSP).
During the two congress days there will be 10 debate sessions which themes will be:
1. European Medicine Agencies – What to expect in the near future
2. Eudravigilance updates – Experience gathered following one year from the implementation of the new requirements
3. Impact of new requirements on PV process
4. PV Quality System and impacts from the new Eudravigilance requirements
5. Patient Support Programmes (PSP)
6. Signal Detection
7. Risk Management and Risk Minimization
8. Contracts and Outsourcing on Pharmacovigilance
9. Digital media on pharmacovigilance
10. Patient Engagement for Set Up of more appropriate Risk Minimization Measures
Moreover, it will not miss the occasion to compare with other realities of the pharmaceutical, clinical and regulatory sector and to discuss about the continuous and growing pharmacovigilance development, thanks to round-tables and networking lunches.