When: 8-10 May 2019
Where: Wings Hotel, Rotterdam Airport, Rotterdam, The Netherlands
Start: Day 1: 15:00 | End: Day 3: 16:00
Course overview
The module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the management of global regulatory operations and strategic planning. It will cover:
- Strategic regulatory options for planning global drug development programmes
- Interactions between industry and regulatory agencies
- Processes for preparing strategic regulatory documentation for gaining marketing authorisation
- Commercialisation of a product
- Global regulatory strategic drug development
- Aspects of project management and strategic planning of the regulatory activities for global drug development programmes
- The module will also provide training in approaches to anticipate regulatory problems and analyse complex regulatory situations
- The optimal strategy to achieve marketing approvals worldwide in a timely manner
- Electronic common technical requirements for reimbursement
- Trademark and patent considerations
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.
Benefits to delegates
This course will enable you to:
- Demonstrate a systematic understanding of knowledge, and a critical awareness of the theory and practice of global strategic planning strategies as they relate to obtaining regulatory marketing authorisation and pricing negotiations
- Display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes
- Demonstrate an in depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes
- Critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development
- Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of drug development
- Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
The latest course programme can be downloaded here
Presenters
- Christine Degeling - Associate Director, CMC Regulatory Affairs, MSD (Netherlands) (MODULE LEADER)
- Marga Oortgiesen - Senior Clinical Programme Director, UCB (USA)
- Connie van Oers - Senior Consultant, Xendo BV (Netherlands)
- Mohamed Oubihi - CEO, Yakumed Ltd (UK)
- Elliot Simonian - Senior Director, Regulatory Affairs, PPD (UK)
- Ineke Jonker-Hoogerkamp - Consultant, Regulatory Affairs and Drug Development, Eagle Pharma Consult (Netherlands)
- Geoff Williams, Executive Director, International Regulatory Affairs Operations, MSD (UK)
- Carolyn Hynes, Head of Global Regulatory Intelligence, GSK (UK)
- Hayden Holmes, Senior Research Consultant, York Health Economics Consortium (UK)
- Maaike van Dartel, CBG-Medicines Evaluation Board, (Netherlands)
- Elke Litzlbauer - Associate Director, External Manufacturing, Takeda (Netherlands)
- Sjaak Bot - Vice President, Regulatory Affairs, Johnson & Johnson (Netherlands)
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire
Suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their strategic planning
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places for those working in regulatory or government agencies or academic institutions, charities and patient groups or in full time education only are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
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Those working for regulatory agencies, government agencies or academic institutions
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£1275+VAT
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Those working for charities, patient groups or in full-time education
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£1275+VAT |
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- VAT, if applicable, is charged at the rate of 21%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee
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Related courses:
MSc Module 6: Regulatory Strategy: From Development to the Market Place
Orphan Drugs
Next steps
Module 10: Leadership and Strategic Management in Regulatory Affairs
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions