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5TH ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT

18 - 20 September 2018 - Vienna
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PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

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

Diogo
LOPES

Head of Global PV System & Standards

CONFERENCE TOPICS 2018

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Navigating through PV inspections – from announcement to CAPA
  • Latest trends in Adverse Event Reporting from Social Media
  • Implementation of GVP Rev 2 – Actual experience
  • Multi Criteria Decision Analysis in drug development – practical examples from a development program
  • Could be Pharmacovigilance considered as a thermometer for business?
  • Enhanced EudraVigilance System – future perspectives
  • Benefit-risk evaluation of anticancer medicinal products at entry into human in a changing environment: a review of EMA/CHMP/205/95 Rev.5 guideline
  • Quantitative benefit-risk assessment and patient centricity
  • Patient Support Programmes and Market Research from PV standpoint

DESIGNED FOR

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, and Heads of departments from pharmaceutical industry involved in:

  • Pharmacovigilance
  • Drug Safety
  • Safety & Risk Management
  • Signal Detection
  • Benefit-Risk Assessment
  • Safety Evaluation
  • Regulatory Affairs, Pharmacovigilance
  • PV Governance
  • Safety Surveillance
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Market Research Programs
  • Clinical Safety
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology

CASE STUDIES

PAST CASE STUDIES INCLUDE

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

Diogo
LOPES

Head of Global PV System &
Standards

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

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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