Event Details
- Course
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This event has been completed
Regulatory Affairs Strategies - April 15, 2014 - April 16, 2014
- Radisson Blu Edwardian Grafton
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London, United Kingdom
- Introduction
- This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.
This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.
What Will You Learn?
Formulate regulatory strategies that achieve first class regulatory performance and compliance
Speed up drug registration through skilled utilisation of registration procedures
Reconcile R&D, clinical and marketing demands within the regulatory framework
Manage the practical hurdles of submitting MAA/CTD within the deadlines
Negotiate and respond to regulators’ questions successfully
Understand the impact for your RA strategy of your product’s therapeutic area, proposed indications and other technical and development features
Collect and present key information for the submission dossier to achieve a winning strategy
Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from regulators
- Useful Links
- Reference link 1
- About Organiser
- Pharmaceutical Training International (PTI)
- T: +44 0 20 7017 7481 F: +44 0 20 7017 7823
- E: registration@pti-europe.co.uk
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