Also available as a face to face course, please click here for the face to face registration option

Course overview

Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements for carrying out clinical research, including the latest requirements for IMPD preparation and good distribution practice, ethical and regulatory approval, clinical trials with medical devices and ISO14155, good clinical practice standards, preparation of clinical trial reports, the more demanding requirements of pharmacovigilance and also the legal aspects relevant to clinical trials such as data protection, insurance and codes of practice. 

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

• Students will understand the practical aspects of Good Clinical Practice and how it supports clinical research.
• Students will be able to identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and the requirements and practicalities of preparing the required clinical trial applications and associated documentation.
• Students will gain an insight into the complexities and requirements of pharmacovigilance in clinical research.
• Students will be able to understand the management of clinical trial supplies.
• Students will be able to understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products.
• Students will be able to understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections.
• Students will gain an appreciation of the legal and ethical aspects of clinical research, including insurance, indemnity and the role of the ethics committees and safety boards.

CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

The draft copy of the  course programme can be downloaded HERE

Module Leader

The latest course programme will be available closer to the event.

Angela Stokes Vice President, Regulatory Affairs Services Sharp Regulatory Consulting

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.

	Eva Kopecna Head of Global Regulatory, Pharmacovigilance and Medical Affairs Acino International
Speakers Rachel Mead - MHRA Simon Craige - EdGe Toxicology Consulting Beatrice Panico - MHRA Adela Williams - Arnold and Porter Mohamed Oubihi - Yakumed Sarah Roberts - PRAHS

• Students of the MSc programme
• Delegates from the regulatory affairs industry who wish to develop their knowledge of clinical operations
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing

Standard

• TOPRA MSc students: £1500 +VAT*
• Delegates:                         £1700 +VAT*

Discounted places

A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: £1275+VAT*.

Please email us at meetings@topra.org for a discount code before making your booking.

*VAT, if applicable, is charged at the rate of 20%.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.