European Filing and Registration Procedures for Drug Approval

Registration and applications within the European Union can follow various procedures depending on the type of product and the objectives of the sponsor. The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. This webinar will review each type of application, when it is required and when it is recommended, along with pros and cons of each type.

An experienced ex-regulator will deliver this course and provide a comprehensive overview of the regulatory filing requirements in Europe. The course will be of value to both those who are new Regulatory Affairs in the pharmaceutical, biopharmaceutical industries, as well as experienced professionals wishing to refresh their regulatory knowledge. Personnel whose responsibilities require knowledge of the EMA and European country regulatory environment, such as Project Managers and those in Clinical, Non Clinical, Manufacturing and Quality areas will also find this training highly relevant.

Areas Covered in the Session :

• 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

Who Should Attend:

• 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
• All companies developing drugs or biologics for approval in the EU

Course Director: PEGGY J BERRY

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 Dey Pharma (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).