When: 1-3 December 2021
Where: CCT Venues, 193 Marsh Wall, London, E14 9SG
Day 1 start time: 10:30 GMT | Day 3 end time: 15:00 GMT
Also available as a virtual course, please click here for the virtual registration option
Regulatory affairs has always involved dealing with large quantities of data, from nonclinical data to post-market pharmacovigilance. The complexity of the analysis is increasing.
This course will cover:
- data management in daily RA work
- EMA telematics strategy
- EMA's collaboration and strategy
- archiving of RA documents
- regulatory information and management
- regulatory intelligence and knowledge management
- big data approaches to regulatory affairs
Benefits to delegates
This course will enable you to:
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.
- Explain the importance of data, document and information management
- Demonstrate a critical understanding of the processes and requirements necessary for completing an eCTD
- Critically evaluate the IDMP requirements
- Identify issues with electronic compliance
- Make recommendations about regulatory information management and IDMP strategies
- Critically analyse data and documentation strategies and processes
- Critically appraise regulatory processes and documentation
A copy of the current programme is available to download HERE
- Peter Embley - Senior Vice President, Regulatory & Health Economic Science at Bionical Emas
- Students of the TOPRA MSc programme
- Delegates from the medical device industry who wish to develop their knowledge
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
- TOPRA MSc students: £1500 +VAT*
- Delegates: £1700 +VAT*
A limited number of discounted places are available at the rates below. Please email us at firstname.lastname@example.org for a discount code before making your booking.
- Those working for regulatory agencies, government agencies or academic institutions: £1,275+VAT*
- Those working for charities, patient groups or in full-time education: £1,275+VAT*
*VAT, if applicable, is charged at the rate of 20%.
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.