Start Time :
March 22 @ 11:00 AMFinish Time :
March 23 @ 3:30 PMPIPA Global Forum – MI & PV Day, 22nd & 23rd March 2021
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 – Brian Edwards, NDA GroupHow will Global Britain adapt to the growing and emerging global pharmacovigilance (PV) system? As PV progresses in many countries this accentuates previous regulatory differences in the main ICH regions and the PV professional will need to adapt and remember the guiding principles that have been laid out by ICH and CIOMS. New technologies will drive change and require system redesign so that they can be efficiently implemented. Global initiatives about aggregate reporting and benefit-risk are making progress to help create a more efficient quality system throughout the lifecycle of a healthcare product. |
| 13.15 – 14.00 | Lunch |
| 14.00 – 15.00 | A comparison of RMP and REMS risk management systems: What considerations and lessons can be learned? – Nancy Dubois, Alexion
This program will provide an overview of the similarities and differences between RMP and REMS risk management systems. In addition, this program will provide best practices and suggestions on how one might leverage the different strategies to reduce barriers to treatment while also ensuring patient safety and regulatory compliance in the ever-changing healthcare landscape. |
| 15.00 – 15.15 | Comfort Break |
| 15.15 – 17.15 | QPPV Hot Topics – Jackie Roberts, Accord Healthcare; Tom Nichols, Drive Phase PV; Janine Gavin-Poulter, Perrigo Company Ltd; Anne Lloyd, Ethypharm & Martindale Pharma
A panel discussion and open forum on the hot topics facing QPPVs globally, including: – Changes in organisational structure due to Brexit – Outsourcing QPPV roles, in large organisations – Local QPPV responsibilities and their management – Ensuring QPPV oversight of non-PV activities |
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; Simon Johns, IQVIA Medical Information teams are developing conversational AI self-service capabilities locally and globally in order to meet growing HCP and patient engagement 24/7/365. With different regulatory, compliance, label and data requirements across marketing, how do Med Info decision makers develop and deploy solutions that meet local requirements and global governance? In this session, we’ll explore how Life Science companies are building the Med Info organization of 2025, delivering digital experiences at scale across channels, languages and geographies while generating rich data and insights. |
| 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:
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| 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
Exploring the laws and regulations that impact medical information provision in the US. |
