- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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Introduction to European Regulatory Affairs
20 - 22 August 2013 , Radisson Blu Edwardian Grafton
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PROPOSE
...a registration strategy for a product and learn best practice dossier preparation to gain speedy regulatory approvalPRACTICAL EXERCISES
...that will enable you to apply what you have learned to your daily workUNDERSTAND
...the European legal and regulatory environmentINTERACTIVE EXERCISES
...participants will experience and understand the practical differences when filing variations or extension applications
Introduction to European Regulatory Affairs
Course Objectives
Optimising “time-to-market” is an increasingly critical requirement for pharmaceutical companies who arechallenged by shrinking pipelines. Tighter standards imposed by regulatory authorities have almost certainly
contributed to a drop in the number of products being launched globally each year.
Are you looking for ways to improve your regulatory affairs activities and optimise drug submission procedures?
This course will provide you with a clear understanding of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.
What Will You Learn?
Performance and Knowledge Objectives
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Understand how to make a clinical trial application in the EU |
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Clarify how the Centralised Procedure works and the function of CHMP |
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Integrate CTD requirements from the start of your submissions |
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Facilitate successful review of your dossier by preparing a strong dossier |
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Allow a smooth product development programme |
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Gain faster response from the Regulators through better negotiations |
Why you should attend
The ‘Introduction to European Regulatory Affairs’ course provides an overview of current EU regulatory requirements and procedures for human pharmaceuticals. The emphasis is on procedural, practical and general requirements. Interactive exercises and discussion are an integral part of the programme.
Those new to regulatory affairs, returning after a career break or requiring an overview of all aspects the European regulatory environment will find the course useful. It will also be of value to personnel requiring knowledge of how regulatory affairs influences the pharmaceutical industry, including those involved in development, manufacturing, project management or business planning.
Course reviews
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"It's a good course and has excellent speakers" - Pharmacist, Saudi Food & Drug Authority "Very extensive and useful information" - RA Officer, Dada Consultancy B.V. |
Dates and Venues
20 Aug 2013 - 22 Aug 2013
Radisson Blu Edwardian Grafton
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
