When: 31 January - 2 February 2024
Where: TOPRA office, 6th Floor, 3 Harbour Exchange, London E14 9GE
Day 1 start time: 10:30 | Day 3 end time: 15:00
Also available as an online course, please click here for the online registration option
Course overview
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
Digitilisation
EMA telematics strategy
eCTD
EMA's collaboration and strategy
Archiving of RA documents
CSV
Regulatory information and management
Regulatory intelligence and knowledge management
IDMP
Big data approaches to regulatory affairs
Benefits to delegates
This course will enable you to:
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
Suitable for
- 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
CPD: This course provides 15 CPD hours on successful completion. To learn more about why continuing professional development is important, visit our Lifelong Learning page.
Programme
A copy of the current programme can be downloaded HERE
Module Leader
Peter Embley
Presenters
Remco Munnik – Director at Iperion (a Deloitte business)
Dennie van de Voort – Junior Manager at Iperion (a Deloitte business)
Dorien de Vries – Senior Consultant at Iperion (a Deloitte business)
Amy Williams – Director at Iperion (a Deloitte business)
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.
Remco Munnik, Director, Iperion Life Sciences Consultancy
Pricing
Standard
- TOPRA MSc students: £1,545 +VAT*
- Delegates: £1,785 +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: £1,338.75 +VAT*
- Those working for charities, patient groups or in full-time education: £892.50 +VAT*
*VAT, if applicable, is charged at the rate of 20%.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.
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.