PIPA Global PV and MI Forum – 22nd & 23rd March

We were delighted to hold our first ever two-day global forum on 22nd & 23rd March 2021. With one day focusing on global pharmacovigilance, and the other on global medical information topics, we delivered a fascinating and truly global programme.

Pharmacovigilance Day – Monday 22nd March 2021

Agenda

11.00 – 12.00 The Impact of Brexit – John Barber, Plain Pharma Consulting Ltd

‘Brexit is Brexit’ was Theresa May’s promise. Four years later, Brexit has now been delivered. This session will review the immediate impacts of Brexit on pharmacovigilance and device vigilance, but will also consider some of the potential future impacts. Are there any broad, sunlit uplands for pharmacovigilance?

12.00 – 12.15 Comfort Break
12.15 – 13.15 The globalisation and harmonisation of pharmacovigilance regulations – Shelley Gandhi, NDA Group
13.15 – 14.00 Lunch
14.00 – 15.00 Risk Minimisation – Nancy Dubois, Alexion
15.00 – 15.15 Comfort Break
15.15 – 17.15 QPPV Hot Topics – chair: Jackie Roberts, Accord Healthcare

 

Medical Information Day – Tuesday 23rd March 2021

Agenda

09.00 – 09.45 Exploring the laws and regulations that impact global medical information provision PART 1 – EU & Asia Pacific – Erin Gentry, Consultant
An exploration of the European and Asia Pacific environments and considerations for medical information activities in these regions with a focus on legislation, regulations and codes of practice. Taking this into the day to day – what are key factors in localising global responses?
09.45 – 10.00 Comfort Break
10.00 – 11.00 Delivering a Global Chatbot Solution: key considerations for a scalable medical information capability – Shai Blackwell & Richard Marcil, ConversationHEALTH
11.00 – 11.15 Comfort break
11.15 – 12.15 The challenges of delivering a truly global medical information database – Liz Rance, Head of EMEA Medical Information, Eisai Ltd
Our journey so far on implementing a global medical information database. Key considerations including configuration, local requirements/regulations, phased roll out, data privacy, document subtypes & workflows, AE forms, email & response templates, roles and permissions, UAT/validation, training and reporting.
12.15 – 13.15 Lunch
13.15 – 14.30 Discussion session: compliance and the global medical information function – Chair: Charlotte Mason, Sanofi

In her session, Charlotte will chair discussions on the following:

  • Localising global MI responses
  • How to answer questions about medicines when the patient is in the UK and the product is licensed abroad – and vice versa
  • Global copyright considerations
14.30 – 14.45 Comfort Break
14.45 – 15.30 Exploring the laws and regulations that impact global medical information provision PART 2 – USA – Seema Patel, Rakuten Medical

To meet the companies that sponsored this event, please go: https://pipaonline.org/pipa-sponsors/