EU Registration & Applications

    /Peggy  /J. Berryspeaker of Training Doyensinvite
    Speaker: Peggy J. Berry


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    Duration: 90 Minutes
    Product Code: 50407
    Level: Intermediate

OVERVIEW

  • Regulatory Pathways to Drug Approval across the EU,
  • Which Pathway is Mandatory for Specific Types of Products,
  • What are the Advantages and Disadvantages of Each Procedure Type,
  • What are the Expectations for Content and Review Timelines for Each Procedure

WHY SHOULD YOU ATTEND

Registration and applications within the European Union can follow various procedures depending on the type of product and the objectives of the sponsor. This program will review each type of application, when it is required and when it is recommended, along with pros and cons of each type.

AREAS COVERED

  • How to choose the appropriate pathway to drug approval in the EU
  • Steps required prior to submission of a marketing authorization application (MAA)
  • Key timelines before, during, and after submission of an MAA
  • Expectations of the sponsor during the review process
  • Follow up on applications after approval
  • Life cycle management of the MAA

LEARNING OBJECTIVES

Learn about the various types of registrations and applications within the European Unionfor drug approval, their purpose and pros and cons.

WHO WILL BENEFIT

  • Vice Presidents, Directors, & Managers of regulatory, clinical, and manufacturing areas.
  • Employees involved in any area providing information for a MAA.
  • All Regulatory affairs personnel working on EU submissions.

SPEAKER

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development.  She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.  Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).  She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and DeyPharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).  In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.  She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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