Thu, Dec 27|
Industry event: Global PV operations and oversight (2)
Challenges maintaining a globally compliant approach across local requirements
Time & Location
Dec 27, 2018, 11:00 AM – 3:00 PM
Rådhuspladsen 4, Rådhuspladsen 4, 1550 København V, Denmark
About the event
Managing pharmacovigilance (PV) across the globe is an increasingly difficult task. The role of the QPPV and associated oversight responsibilities are today multi-faceted, demanding global-local understanding and fast flow of information across HQ, affiliates and CROs/partners. The drive for building localized legislative frameworks for PV also represent a significant workload on regulatory intelligence and legal staff of pharma companies. How are these challenges best managed? How should the division of responsibilities across global-local entities look like optimally? And where could automation be most useful?
Learn more about impact of regulations, processes and technologies to support your business. Meet colleagues from industry, understand challenges and get ideas for actions to take.
This event is held by Insife, Oracle Health Sciences and DLA Piper and is free to attend.
The intended target audiences are PV leaders, QPPV's, QPPV-office / Regulatory Intelligence staff, PV technology staff, Legal representatives, local operating PV represenatives and CROs.
11:45-12:30 Networking lunch
12:30-12:50 Challenges maintaining compliant PV operations in a world of changing regulations
Welcome / event introduction
Macro-trends in the global environment and current and upcoming impacts for pharma
by Martin Holm-Petersen , CEO, Insife
12:50-13:20 Navigating global markets from a legal viewpoint
Considerations for pharma companies on global litigation risks
General Data Protection Regulation (GDPR) update
by Marlene Plas, Partner, Lawyer, DLA Piper
13:20-14:05 Novo Nordisk’s QPPV office
Thoughts on current challenges and priorities for the future at the Novo Nordisk QPPV office
by Pilar Carrero , VP, Novo Nordisk
14:30-15:30 Safety database and beyond - evolving to continuously meet global regulatory compliance
What are the learnings from the EudraVigilance rollout since November, and what can we expect with R3 in Japan from April 2019?
Configuring the safety database for GDPR compliance / good practices for site security etc.
What key changes have been introduced in the past releases of the Argus safety suite and which changes are expected in the near future?
What are the options when automating global PV? E.g. Translations, Patient support programs, market research programs, literature monitoring. social media scanning etc?
by Michael Braun-Boghos , Director, Oracle
15:30-16:00 Discussing and sharing challenges and priorities
A major challenge - The rising volumes of ICSRs occurring
from patient support programs all over the world is
proving to be one of the biggest issues for PV operations
What are the barriers to achieving efficient processing and
are there any best-practices emerging?
by Joseph Lovett, Director, MyMedsandMe
16:00-16:30 Orchestrating processes between local and global organizational entities
Examples of where processes typically become sub-optimal due to lack of efficient technology, across stakeholders in the global business
Finding ways to replace spreadsheets and secure an effective end-to-end process
Options for automation inline in the process
by Peter Stroyer Pallesen , Director, Insife
16:30 Meeting end