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RAI Center

2013 年 03 月 04 日 9:00 上午 - 2013 年 03 月 06 日 5:30 下午

Europaplein, 1078 GZ Amsterdam, Netherlands

25th Annual EuroMeeting

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Continuing-Education

Short Course or Primer

To keep you at the forefront.

2013 年 03 月 04 日

Roundtable 01:

GCP Inspections and Audit Findings

2013 年 03 月 04 日

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

2013 年 03 月 04 日

Tutorial 02:

Analysis of Safety Data from Clinical Trials

2013 年 03 月 04 日

Tutorial 03:

Update on Practical Work with Variation Regulation

2013 年 03 月 04 日

Tutorial 04:

Introduction to Medical Device Regulation

2013 年 03 月 04 日

Tutorial 05:

Recent and Current developments in Pharmaceutical Law

2013 年 03 月 04 日

Tutorial 07:

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

2013 年 03 月 04 日

Tutorial 08:

Health Technology Assessment of Drugs and Medical Devices

2013 年 03 月 04 日

Tutorial 09:

The European QP for Pharmacovigilance

项目委员会

  • 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 Services a.s., 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 Independent Regulatory Science Expert
    Independent, 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 Head of Agency
    Croatian Agency for Medicinal Products and Medical Devices, Croatia
  • Hans  van Bruggen, MSC
    Hans van Bruggen, MSC Director of Regulatory Affairs
    Celegence, United States
  • Jan Willem  van der Laan, PHD
    Jan Willem van der Laan, PHD Senior Assessor Pharmacology and Toxicology
    Retired From 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 Drug Development and Regulatory Affairs - MSC Course
    University of Applied Sciences, Germany
  • Ning  Xu, MD, MBA
    Ning Xu, MD, MBA Executive Vice President, Head of Global Clinical Operations, Zailab
    Zai Lab, China
  • Peter  Bachmann
    Peter Bachmann Retired from Head International Liaison Office and Conferences, Executive Depart
    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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