When: 30 January -1 February 2019
Where: De Vere Latimer Estate, Chesham, UK
Start Day 1: 16:00 | End Day 3: 16.00
Course Overview
Lectures and workshops will cover the understanding and application of modern approaches and understanding of managing and building a regulatory department including:
- Training for a regulatory department
- IT Support
- Regulatory intelligence
- Collaboration with other departments such as pharmacovigilance
- Marketing
- Quality control
- Regulatory Operations
- Negotiation skills
- Business planning
- Budgeting and registration fees
- The politics or regulation (influencing and lobbying)
- Product development plans and regulatory project planning and decision analysis
- Portfolio Management
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 critical knowledge of how to liaise and collaborate with other departments to ensure the appropriate documentation used in development, maintenance and commercialisation of medicinal products and medical devices is in place
- Possess a comprehensive understanding of the legal requirements and management theory governing regulatory strategies to product development, maintenance and commercialisation
- Demonstrate the ability to understand the management and leadership skills required to run a regulatory affairs department as a manager, a leader or a member of the RA team
- Deal with complex issues both systematically and creatively, make sound management judgements in the absence of complete data and communicate your conclusions to the specialist audiences including working with other departments
- Critically appraise and evaluate communications from regulations, guidelines, research and other publications regarding the management of a regulatory affairs department.
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
Download this event's agenda
Module Leaders
Presenters
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 knowledge of the requirements for a new active substance
- 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 are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
Those working for regulatory agencies, government agencies or academic institutions
|
|
£1275+VAT
|
Those working for charities, patient groups or in full-time education
|
|
£1275+VAT |
|
- VAT, if applicable, is charged at the rate of 20%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee.
Related courses
Practical Document Writing and Management in Practice
Interacting with your Regulator Workshop
Module 6: Regulatory Strategy from Development to the Market Place
Next steps
Module 1:Strategic Planning in Regulatory Affairs
Register now
Simply log in or create an account and register below.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions