International Pharmacovigilance Days

Pharmacovigilance is ‘hotter’ than ever. A simple search on Social Media can give a good idea of the impact of pandemic on Pharmacovigilance. How the perceptions of clinical research, drug approval and adverse events among the public have evolved; adaptations to the regulatory framework to address challenges arising from the current situation; and the change to the way that ‘PV people’ work.

At the same time, Brexit and implementation of the new regulatory base of pharmacovigilance in the UK, as well as in the Eurasian Economic Union (EAEU) countries, have transformed Pharmacovigilance to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Pharmacovigilance has been discussed as a concept for integrated regulations. Considering the recent developments, are we Getting Closer or Further Away from Harmonized systems?

The third edition of the International Pharmacovigilance Days, organized by LS Academy, will focus on all these topics, among others:

• What are the points to be considered when a PV system is set up outside the EU?
• What are the inspection and quality aspects challenges under the new Legislation Era?
• Is a transition from an EU-QPPV Office to International QPPV Office required?
• How has the COVID-19 affected the digital transformation of PV? Is this ‘new way we work’ here to stay?
• PV Technologies reality check – where do we stand? Are the promises of technology coming true?
• Are new PV business models required to meet current and future needs? Pharmacovigilance outsourcing and vendor oversight – what are the trends and best practices?
• Current discussions for accelerated drug approval and safety monitoring: Will they have a further impact on patients’ involvement on drug development?

The conference will be divided in 5 virtual appointments from 14th to 18th June (afternoon CEST – 2,5 hours each).

The Agenda will cover 3 main macro-areas:

• Globalization of Pharmacovigilance: Getting Closer or Further Away from Harmonized Systems?
• Pharmacovigilance System: Best Practices and Case Studies
• Patient Involvement in Drug Development and Vaccines

Check the website for the programme