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 latest course programme will be available closer to the event.

Speakers

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.

	Graham Bell Associate Director, Regulatory Strategy & Agency Liaison  PRA Health Sciences
	Simon Craige Consultant Toxicologist EdGe Toxicology Consulting
	Eva Kopecna Head of Global Regulatory, Pharmacovigilance and Medical Affairs Acino International
	Pierre Omnes Executive Director, SSU and Regulatory Syneos Health
	Mohamed Oubihi CEO Yakumed
	Beatrice Panico Senior Medical Assessor Medicines and Healthcare products Regulatory Agency (UK)
	Angela Stokes Vice President, Regulatory Affairs Services Synteract
	Sarah Roberts Vice President and Head of Global Regulatory Affairs PRA Health Sciences
	Emma Whale Senior GCP and GLP Inspector Medicines and Healthcare products Regulatory Agency (UK)
	Adela Williams Partner Arnold & Porter

Suitable for

• 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

Related courses:

Module 3:  Regulatory Requirements for a New Active Substance: Quality
Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development

Next steps

Module 6: Regulatory Strategy: From Development to the Market Place

Terms and conditions

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