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 An Overview of European Regulatory Affairs; Understanding the Issues for Effective Global Development

For the FIRST time outside Europe, The Organisation for Professionals in Regulatory Affairs (TOPRA) conducted the Regulatory Affairs Workshop titled "Effective Global Drug Development and Regulatory Approval Success", in conjunction with the University of Hertfordshire (UK) and the Pharmaceutical Society of Singapore (PSS) Industry Chapter. The event was held at the Oasis Hotel on 19 & 20 May 2014. 

This event was very well received, with 24 participants from the pharmaceutical industry. Our 4 highly qualified speakers included:

1.     Sue Harris, UK Expert for the Committee on Human Medicinal Products, UK Alternate Delegate to the Herbal Medicinal Products Committee, European Medicines Agency (EMA)

2.     Lynda J Wight, Executive Director of TOPRA, Fellow of Royal Society of Medicine

3.     Bob Clay, Regulatory strategist, Highbury Regulatory, Chief Regulatory Officer, Kinapse

4.     Matthew Taylor, Dean of Pharmacology, University of Herfordshire, UK

This informative workshop provided great insights to the EU regulatory procedures, key players and principal systems. Participants were also given tips on how to optimize interactions with EU regulatory agencies. New developments and current issues in EU regulatory affairs which include clinical trials, pharmacovigilance and paediatrics were also shared. Common pitfalls of CMC data applications were addressed and how to optimally implement a global regulatory strategy was highlighted. Participants also had the opportunity to have a better understanding of TOPRA and the role it played as a professional association.

A useful overview of postgraduate qualifications in regulatory affair was also introduced and of great relevance, Masters in Regulatory Affairs by the University of Hertfordshire.

The workshop concluded with an group exercise (which allowed more interactive learning) on how EU regulators review submissions.

This 2-day course provided a great avenue for networking of regional regulatory professionals in Singapore. It also enabled participants to have their queries involving EU regulators and MHRA professionals answered. 

The overall feedback was positive and these workshops were of high value to all who participated. Participants hope to have more of such courses in the near future.

The workshop ended on a high with a dinner and networking session in the evening at Alumni Association.

Reported by:

Ivan Chew


Industry Chapter

108th Council