3rd Annual Pharmacovigilance & Risk Management Summit
21-22

February 2017

Germany

Berlin

Hotel Riu Plaza Berlin

Martin-Luther-Straße 1, 10777

About Summit

Our 3rd Summit will gather PV professionals to discuss strategies for prioritizing compliance and quality through new technology and collaboration. The extensive group of experts will discuss the advances and new trends in EU legislation, audit and inspection preparation, signal detection practices, implementation of risk management plans, the impact of IT and social media on PV, and harmonization of different regulatory bodies.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders and Managers specialising in:

  • Pharmacovigilance
  • Product Safety
  • Qualified Persons Responsible for Pharmacovigilance QPPV
  • ICH-GCP
  • Signal Management
  • PSUR/PBRER
  • PASS/PAES
  • Adverse Drug Reactions (ADR)
  • Drug Safety
  • Risk Management
  • GPvP
  • PV Inspection and Audit
  • Signal Detection
  • PV Agreements
  • PSMF

From Industries Including:

  • Pharmaceuticals
  • Hospital
  • Biotechnology
  • Clinical Research Organizations
  • Regulatory Agencies
  • Health Care
  • Medical Practice
  • Biologics
  • Academic Research Centers
Key Practical Learning Points of the Summit

Good signal detection practices
New approaches to signal management
The benefits of Risk Management and monitoring the effectiveness of risk minimization
European safety and Risk Management of biosimilars
Planning and preparing for Pharmacovigilance inspections according to the various requirements
Implementation of a Pharmacovigilance System Master File and inspection preparation
Latest innovations and trends in drug safety
Speakers
Dr. Cedric Bousquet

Researcher in pharmacovigilance & knowledge engineering

INSERM U1142/LIMICS, France

Dr. Frank Schippers

VP Global Clinical Development

PAION Deutschland GmbH

Dr. Inge Lefèvre

Deputy QPPV Vacines, Vaccines Clinical Safety & PV (VCSP)

GlaxoSmithKline Vaccines

Dr. Mircea Ciuca

Head Medical & Clinical Drug Safety

Vifor Pharma

Dr. Peter De Veene

Senior VP, Head Global Drug Safety & QPPV

Grünenthal Group

Dr. René Haltiner

Managing Director / Senior PV Strategy Lead Conceptual Process Solutions

GmbH / F. Hoffmann-La Roche Ltd

Dr. Steinar Madsen

Medical Director Department of Drug Information

Norwegian Medicines Agency

Dr. Tanja Peters

Deputy EU-QPPV & Head PV Intelligence

Boehringer Ingelheim Pharma GmbH & Co. KG

Isabelle Lalande-Luesink

Global Head PV Operations, CMO & Patient Safety

Novartis Pharma AG

Marie-Laure Kürzinger

Global Pharmacoepidemiologist, Global PV & Epidemiology

Sanofi

Prof. Saad Shakir

Director

Drug Safety Research Unit

Annual

Events

Previous Year Attendees
  • Bayer Pharma AG Germany

    Vice President, Head of GMA WH&EP

  • Bayer Pharma AG Germany

    Senior GMA Physician

  • LLC Teva Ukraine Ukraine

    Person responsible for Pharmacovigilance

  • F. Hoffmann-La Roche Switzerland

    Business Solution Manager

  • Bayer Pharma AG Germany

    TA Head Risk Management GPVCC

  • Bayer Pharma AG Germany

    Global Clinical Leader and Global Safety Leader

  • Heaton k.s. Czech Republic

    CEO

  • Roche China Holding Limited China

    Safety Science

  • Elsevier Information Systems GmbH Germany

    Solution Marketing Manager and Global Vendor Relations Manager

  • Debiopharm International, Switzerland

    Senior Pharmacovigilance Officer

  • Biogen International HQ Germany

    Medical Operations/PV

  • Biogen GmbH Germany

    Medical Operations/PV and Head of Drug Safety

  • Stallergenes SAS France

    Head of Drug Safety Evaluation EU QPPV

  • Quintiles Germany

    Senior Director Business Development RWLPR

  • Elsevier B.V. The Netherlands

    V.P. Solution Sales Life Sciences

  • GlaxoSmithKline (GSK) Belgium

    VCSP Global Process Owner

  • Institut de Recherches Internationales Servier France

    Biostatistician

  • Elsevier B.V. The Netherlands

    Regional Manager Pharmaceutical Biotech Mature Europe



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