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SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

CASE STUDY / DAY 1

Navigating through PV Inspections – from announcement to CAPA

The presentation summarizes the current practice of Inspection of PV system and gives an overview of how to navigate through the preparation and conduct of a PV Inspection as well as responding to observations, including corrective/preventive action (CAPA) plans. It will share best practice and give hints to prepare their organisation regarding roadmap, involved teams, tasks, and documents.

  • Typical Inspection process: announcement, conduct, reply
  • Inspection preparation: pre-document request, training, Q&As, logistics
  • Inspection conduct: behaviour, managing document requests
  • Inspection reply: immediate actions, CAPA preparation

Sabine
JECK-THOLE

EU QPPV and Head Regional PV EUCAN & EM

Simon
ASHWORTH

VP, EU QPPV and Head EU Compliance, Marketed Products and PV Affiliate Relations

CASE STUDY / DAY 1

Local and Global Pharmacovigilance Challenges and Opportunities in an Evolving Environment

The pharmacovigilance environment continues to evolve both at a Global, Regional and Local level.  Some of these changes bring opportunities to harmonize practices and communications, but other changes bring challenges to maintain compliance, maintain efficient processes and manage resource and costs. Companies therefore need to keep abreast of evolving local regulations and continually look for synergies in process, which is often done most effectively by ensuring the utilization of local knowledges within the countries.

  • Managing Divergence and Convergence of PV regulations
  • EU style regulations in the Emerging Markets, how to make it fit
  • Importance of having local insight into changing regulations

This year Summit will host speakers from the world’s leading companies.
See sample of key note speakers.

Monica
MARCANO

Director Cluster Safety Lead West Europe (France, Portugal & Spain)

Attila
OLAH

Head Global Pharmacovigilance, QPPV

Rob
VAN MAANEN

Senior Medical Director, Medical Science

Simon
ASHWORTH

VP, EU QPPV and Head EU Compliance, Marketed Products and PV Affiliate Relations

Magnus
YSANDER

EU QPPV and Head Risk Management & Pharmacovigilance Excellence

Sabine
JECK-THOLE

EU QPPV and Head Regional PV EUCAN & EM

CASE STUDY / DAY 2

Implementation of GVP V (Rev 2) – Experiences so far

The updated ‘Guideline on Good Pharmacovigilance Practices (GVP), Module V (Rev 2) – Risk management systems’ has been in place since March 2017, with the adjacent template being mandatory for all products from April 2018. The revised definitions of safety concerns and the modified format for the EU Risk Management Plans are considered a paradigm shift, driving the purpose of the document back to focus on appropriate management of the meaningful risks. This presentation will summarize the practical experiences, from a pharmaceutical company perspective, of implementing the amended GVP, Module V; including interpretation and principles, transition from previous template and approaches, relation to other documents (for example the PBRER) and feedback from regulatory authorities so far.

Implementation of GVP Module V (Rev 2):

  • Main improvements and remaining challenges
  • Practical approaches for transition to new EU RMP standard
  • Initial feedback from regulatory authorities

Magnus
YSANDER

EU QPPV and Head Risk Management & Pharmacovigilance Excellence

Monica
MARCANO

Director Cluster Safety Lead West Europe (France, Portugal & Spain)

CASE STUDY / DAY 2

Latest Trends in Adverse Event Reporting from Social Media

With the increasing popularity of social media, online forum discussions are becoming increasingly significant sources of information about drug use, and as a consequence, they constitute important sources of information on adverse drug reactions. This information can be very valuable for regulators, marketing authorisation holders, healthcare professionals, patients, and other stakeholders.

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See what keynote speakers will be taking part in the exclusive speaking panel.
Explore what Case Studies will be discussed by our senior corporate speakers

5th Annual Risk Management and Pharmacovigilance Summit
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