This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures, and obligations. It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.
Benefits of Attending
- Understand the Legal Basis of the EU Regulatory Environment
- Discuss Development Strategy and Pre-Submission Activities
- Review Procedures for Applying for an EU Marketing Authorisation
- Discuss Post Authorisation Strategic Considerations and Obligations
Why you should attend
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.
It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements.
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Programme Day One
EU Regulatory Environment: Legal basis
- Key Regulations, Directives and Guidelines and information sources
Impact of Brexit
Development Strategy and Pre-Submission Activities
- Scientific advice
- Paediatric use
Case study 1: Submission Requirements
The Common Technical Document (CTD)
- Structure and content of the CTD requirements for sponsor oversight
Applying for a Marketing Authorisation in the EU
- Fast-track, conditional approval and exceptional circumstances
- Adaptive licensing
- Centralised procedure (CP)
- Decentralised procedure (DCP)
- Mutual Recognition procedure (MRP)
- National procedures
Case Study 2: Registration strategy: discussion; will Brexit alter this?
Managing Product labelling
- Company core data sheets
- Updates to Summary of Product Characteristics
Programme Day Two
- Legal basis
- Data exclusivity
- Generics-definition and criteria
Post Authorisation Obligations and Strategic Considerations
- Line extension
- Classification switch
- Parallel trade (Impact of Brexit)
- Type I and Type II variations
- Procedures and timelines
- Case study 3: Post Authorisation Strategy: discussion; will Brexit alter this?
Requirements and procedures
- Periodic safety update reports
- The Sunset Clause
Ms Norah Lightowler,
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 twentieth year of successful business.
Norah has wide experience in the pharmaceutical and related neutraceutical, 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.
This course is for you, particularly if involved in:
- Regulatory affairs
- Project management
- Business planning
- Commercial Managers
- Manufacturing and QA
- Labelling and artwork
- Medical information
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.