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RAI Center

Mar 04, 2013 9:00 AM - Mar 06, 2013 5:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

25th Annual EuroMeeting

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Continuing-Education

Short Course or Primer

To keep you at the forefront.

Mar 04, 2013

Roundtable 01:

GCP Inspections and Audit Findings

Mar 04, 2013

Tutorial 01:

Highlights on the Implementation of the New Pharmacovigilance Legislation with regards to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in Eudravigilance

Mar 04, 2013

Tutorial 02:

Analysis of Safety Data from Clinical Trials

Mar 04, 2013

Tutorial 03:

Update on Practical Work with Variation Regulation

Mar 04, 2013

Tutorial 04:

Introduction to Medical Device Regulation

Mar 04, 2013

Tutorial 05:

Recent and Current developments in Pharmaceutical Law

Mar 04, 2013

Tutorial 07:

The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committeeof the European Medicnies Agency

Mar 04, 2013

Tutorial 08:

Health Technology Assessment of Drugs and Medical Devices

Mar 04, 2013

Tutorial 09:

The European QP for Pharmacovigilance

Program Committee

  • Christer  Backman, LLM
    Christer Backman, LLM International Coordinator & Senior Expert
    Medical Products Agency, Sweden
  • Gesine  Bejeuhr, PharmD
    Gesine Bejeuhr, PharmD Pediatric Regulatory Leader
    Bayer AG, Germany
  • Representative Invited
    Representative Invited European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • Gonzalo  Calvo Rojas, PhD
    Gonzalo Calvo Rojas, PhD Consultant in Clinical Pharmacology
    Hospital Clinic Barcelona, Spain
  • Judith  Creba, PhD
    Judith Creba, PhD Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
    Novartis Pharma AG, Switzerland
  • Luca  De Nigro, MS
    Luca De Nigro, MS Drugs Monitoring Register
    Italian Medicines Agency (AIFA), Italy
  • Vicki  Edwards, RPh
    Vicki Edwards, RPh Vice President, Pharmacovigilance Excellence and International QPPV
    Abbvie, United Kingdom
  • Shayesteh  Fürst-Ladani, MBA, MS
    Shayesteh Fürst-Ladani, MBA, MS CEO
    SFL Regulatory Affairs & Scientific Communication, Switzerland
  • Christine  Gispen De Wied, DrMed
    Christine Gispen De Wied, DrMed Scientific Programmanager
    Medicines Evaluation Board, Netherlands
  • Susanne  Keitel, DrSc, RPh
    Susanne Keitel, DrSc, RPh Director
    European Directorate for the Quality of Medicines & Healthcare (EDQM), France
  • John  Kerridge, PhD, RPh
    John Kerridge, PhD, RPh Director Of Quality, External Manufacturing Europe, Africa, Asia
    LILLY FRANCE, France
  • Andrei  Kravchenko, MD, PhD
    Andrei Kravchenko, MD, PhD Head of Representative Office in Ukraine
    SynteractHCR, Ukraine
  • Jürgen  Kübler, PhD
    Jürgen Kübler, PhD Owner
    Quantitative Scientific Consulting, Germany
  • Hubert  Leufkens, PharmD, PhD
    Hubert Leufkens, PharmD, PhD Emeritus Professor of Pharmaceutical Policy and Regulatory Science
    Utrecht University, Netherlands
  • Hans H Linden, MS
    Hans H Linden, MS Executive Director
    EUFEPS, Sweden
  • Marta  Marcelino
    Marta Marcelino
    Infarmed, Portugal
  • Robert  Middel, MHS
    Robert Middel, MHS Head of External Alliances, Portfolio Delivery Operations
    Janssen Biologics B.V., Netherlands
  • Melek  Onol
    Melek Onol Head of RA
    Boehringer Ingelheim, Turkey
  • Markus Georg Pasterk, MS
    Markus Georg Pasterk, MS COO and Vice President Science
    IPRI, France
  • Jan  Petracek, MD, MSc
    Jan Petracek, MD, MSc CEO
    Ivigee, Czech Republic
  • Lidia  Retkowska-Mika, LLM
    Lidia Retkowska-Mika, LLM Director Legal DPT
    Office For Registration of Med. Products, Medical Devices and Biocides, Poland
  • Isabelle  Stoeckert, PharmD, PMP
    Isabelle Stoeckert, PharmD, PMP VP. Head Regulatory Affairs Europe Middle East Africa PH
    Bayer, Germany
  • Burkhard  Straeter
    Burkhard Straeter Lawyer
    Sträter Rechtsanwälte, Germany
  • Steven  Teerenstra, PhD, MSc
    Steven Teerenstra, PhD, MSc Statistician
    Medicines Evaluation Board, Netherlands
  • Sinisa  Tomic, PhD
    Sinisa Tomic, PhD Counsellor for European Affairs
    Croatian Medicines Agency, Croatia (Hrvatska)
  • Hans  van Bruggen, MSc
    Hans van Bruggen, MSc CSO
    Qdossier, a Celegence Company, Netherlands
  • Jan Willem  van der Laan, PhD
    Jan Willem van der Laan, PhD Senior Assessor Pharmacology and Toxicology
    Medicines Evaluation Board, Netherlands
  • Nermeen Y. Varawalla
    Nermeen Y. Varawalla Executive Vice President, Global Clinical Trials
    Lambda Therapeutic Research, United Kingdom
  • Maren  von Fritschen, PharmD
    Maren von Fritschen, PharmD Head EU Regulatory Policy
    Moderna, Netherlands
  • Ning  Xu, MD, MBA
    Ning Xu, MD, MBA Executive Vice President, Head of Global Clinical Operations, Zailab
    Zai Lab, China
  • Peter  Bachmann
    Peter Bachmann Deputy-Head, European Union and International Affairs
    Federal Institute for Drugs and Medical Devices (BfArM), Germany
  • Beatriz  Vicen Banzo
    Beatriz Vicen Banzo Head of Regulatory Affairs
    Bayer Healthcare, Spain
  • Truus  Janse-de Hoog, PharmD, MSc
    Truus Janse-de Hoog, PharmD, MSc Senior former Staff Member of the Medicines Evaluation Board
    Netherlands
  • Maureen  McGahan
    Maureen McGahan Planning and Development Department
    DIA Europe, Switzerland
  • Katrin  Rupalla, PharmD, MBA
    Katrin Rupalla, PharmD, MBA Senior Vice President
    H. Lundbeck A/S, Denmark

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