Marketing Authorization of Biologicals in the EU What needs to be considered


Category:  A Bridge to the EU ,
Biologics ,
Regulatory Affairs
Lecturer: Dr. Barbara Jentges
 
Course Language: English
Course Name: Marketing Authorization of Biologicals in the EU What needs to be considered
Duration: 2 - Day Course
Date: 14, 15 March 2011
Hours: 9:00am - 5:00pm
Registration: 8:30am
Location: Corporate College East 4400 Richmond Road Warrensville Heights, OH / On Site
Price:  Basic Price: $595/day, Early bird registration- $495/day
Course ID : A10303

Registration Form
 
Developing new biological medicinal products is very capital-intensive and it takes up to 10 to 15 years to bring a new product to the market bearing a high risk of failure. This requires a set of scientific, regulatory and business competencies – among them a profound knowledge of the regulatory hurdles that need to be overcome during pharmaceutical development.

This course focuses on the legislative environment regulating biologicals within the European Union and gives an understanding of the regulatory steps that need to be taken to successfully place a biological on the European market.
Benefits to the Participants
  • Understanding ‘biologicals’ in terms of the EU Pharmaceutical legislation
  • Become aware of regulatory milestone during pharmaceutical development of biologicals
  • Understainding the different roles of EU health authorities in the registration process of biological
  • Becoming familiar with the centralized procedure
  • Learning how to prepare a scientific advice meeting
  • Making use of EPARs to find out what authorities expect and how they interprete the guidelines
  • Learning how to prepare an eCTD submission for biologicals
Issues to be covered

 

Day 1
08.30 – 08.45 Welcome
08.45 – 09.45 ‘Biologicals’ – Wordings and Definitions
  • What are ‘biologicals’ in the terms of the European Pharmaceutical Legislation
  • Advanced Therapy Medicial Products, ‘Biologics’, Biosimilars
  • Special considerations
09.45 – 10.45 Regulatory Milestones during Development of Biologicals
  • Pre-authorisation phase: Pre-clinical phase, clinical development and clinical trial applications; ‘pharmaceutical development’
  • Marketing Authorisation Application
  • Post-authorisation phase
10.45 – 11.15 Coffee Break
11.15 – 12.15 Health Authorities in the EU and their different Roles in the Registration Process of Biologicals - An Overview
  • European Commission – Enterprise and Industry Pharmaceuticals
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • European Medicines Agency (EMA)
  • National Competent Authorities (NCAs)and Heads of Medicines Agency (HMA)
12.15 – 13.15 Lunch Break
13.15 – 14.15 Where to find Relevant EU-Guidelines for ‘Biologicals’ – Surfing the Authorities’ Websites
  • EU: EudraLex, EU-News
  • EMA: Scientific guidelines, procedural aspects, European Public Assessments (EPARs)
14.15 – 14.45

Centralised Procedure mandatory for ‘Biologicals’

  • Legislative background for the centralized procedure
  • Regulatory and procedural aspects; timelines
15.45 – 16.15 Coffee Break
16.15 – 16.45 Centralised Procedure mandatory for ‘Biologicals’
  • Legislative background for the centralized procedure
  • Regulatory and procedural aspects; timelines
Day 2
08.30 – 09.30 Registered ‘Biosimilars’ within the EU – Current Situation
  • Facts and figures
09.30 – 10.30 Comparability Exercise for ‘Biosimilars’
  • Demonstration of ‘Comparability’ for medicinal products of biotechnological origin, what needs to be considered
10.30 – 11.00

Coffee Break
11.00 – 12.00 Scientific Advice Meeting and how to prepare
  • Application form and timelines
  • Preparing the SA meeting (documentation, presentation, etc)
12.00 – 13.00

Lunch Break
13.00 – 14.00

e-Workshop:

  • How to make use of the ‘Community Register’ and the ‘European Public Asssessment Reports’ (EPARs)
14.00 – 14.30 Coffee Break
14.30 – 15.30 How to prepare an eCTD Submission for Biosimilars
  • Granularity of submission documents
  • eCTD-compliant files
  • eCTD – Be aware of regional differences
  • Practical aspects and lessons learn

 
Who should attend
  • Regulatory Affairs Professionals
  • R & D Personnel
  • QA professionals
About the Speaker
Dr. Barbara Jentges is founder and Managing Director of PhACT (Pharmaceutical Advice, Compliance & Training specialised in Drug Regulatory Affairs) GmbH, Switzerland.

Dr. Jentges is a pharmacist with more than 19 years experience in the Regulatory Affairs field, who worked for many years as an external assessor of the Federal Institute for Drugs and Medical Devices (BfArM), Germany. Dr. Jentges is co-author and co-editor of the Guide to Drug Regulatory Affairs, published by Editio Cantor Verlag, Aulendorf, Germany. 

Since 2007 she has been teaching in the Master curriculum Medicinal and Industrial Pharmaceutical Sciences (MIPS) at ETH (Swiss Federal Institute of Technology) Zurich, Switzerland.  Since 2008 she chairs PDAs European Interest Group “Inspection Trends and Regulatory Affairs”.

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