This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post-authorisation strategies and obligations.
The programme will be of value to regulatory affairs personnel and also to those who interact with regulatory personnel in order to understand action timelines and information requirements.
Benefits of attending:
This course will be of particular relevance if you are involved in:
• Regulatory affairs
• Project management
• Business planning
• Commercial management
• Manufacturing and QA
• Labelling and artwork
• Medical information
Welcome and introduction
EU regulatory environment: legal basis
Development strategy and pre-submission activities
Case study 1: Submission requirements
The Common Technical Document (CTD)
Applying for a marketing authorisation in the EU
Case study 2: Registration strategy discussion
Managing product labelling
Post-authorisation obligations and strategic considerations
Case study 3: Post-authorisation strategy discussion
Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.