Compliance with Brexit's Impact on the Global Pharmaceutical industry

Why Should You Attend:

"It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry", said the UK’s Prime Minister Theresa May (1). It is important to consider what’s ahead for the industry, which will allow both UK and global drug development to prosper after Brexit.

Following the UK Brexit Referendum on 23 June 2016, the UK took the historic decision to exit the EU which will result in the UK Government triggering Article 50 of the Lisbon Treaty. This will officially notify the European Council of the UK’s intention to leave the EU. The UK exit of from the EU is the most significant economic demerger between major economies since the Second World War and both the UK and the EU will be significantly changed by this.

Brexit has resulted in a number uncertainties and complexities for drug development taking place in the UK and the EU. Some opportunities will also result. This webinar assesses what key areas of impact of Brexit may have for the pharmaceutical industry and what strategies organizations should be considering.

Learning Objectives:

• Understand the impact of Brexit on the global pharmaceutical industry
• What Brexit actually means: the potential models for the UK’s relationship with the EU
• Consider the challenges and opportunities for Brexit for the global pharmaceutical industry
• Review the implications for the Sponsor for global drug development
• Explore the potential changes for regulatory requirements including clinical approval in the EU
• Consider changes for running trials in the UK and access to the EU
• Review What your pharmaceutical business needs to be considering now

Areas Covered in the Webinar:

• European Medicines Agency (EMA) Relocation and the Medicines Healthcare Products Regulatory Agency (MHRA) impact of Brexit
• EU regulations including Clinical Trial Approval changes
• Employee talent and what organizations should consider under Brexit
• Research funding and collaboration
• What your organization should be considering now to manage Brexit

Who Will Benefit:

The session is relevant for all professionals working pharmaceutical industry, supplies and regulatory authorities.

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Management and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University of Cardiff and Course Director of the MSc Regulatory Affairs, TOPRA. Laura has many years’ experience in the Pharmaceutical Industry. She has worked for several companies including Glaxo Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department.

She is an international expert on clinical trial regulatory requirements. She was Chairman of the Institute of Clinical Research GCP Forum for six years and writes regularly on pharmaceutical regulatory requirements. She is author of several publications including a chapter on “International Pharmaceutical Product Registration” (Informa,), several articles on the new EU Clinical Trial Regulation in 2014 and 2015, and a chapter on Drug Development for the Clinical Research Manual to be published by Euromed Communications in early 2017 and article on Brexit due to be published in early 2017. In her this role, she provides strategic guidance on regulatory and organisational change.

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