Regulatory Affairs Webinar Series: Post-event writeup

May – July 2020

May – July 2020

Zoom Seminar

By Angad Rao and Sowjanya Kallakuri

 

Regulations are made by the government to protect public health by ensuring the safety and efficacy of medicines, vaccines, and medical devices. Based on regional and economic constraints, the regulatory bodies around the globe differ in their guidelines, making it challenging even for regulatory affairs professionals to navigate. To aid in the understanding of these variations, BCS recently organised a three-part webinar-based workshop series on regulatory affairs, given by experts in different domains of regulation in Asia, Europe, and America.

We aimed to highlight the similarities and differences between different regulatory agencies, discuss essential concepts in regulatory affairs, and provide a medium for aspiring regulatory affairs professionals to get valuable career advice from the best in their industry. The webinars were conducted between May – July 2020 and attracted enthusiastic participants from over 17 different countries.

The first webinar of the series titled “The Asian Chapter: Asian Regulatory System Overview and Practical Tips” was held on May 29th and was jointly organised by BCS and the Asia Regulatory Professionals Association (ARPA). Jack Wong, founder of ARPA, delivered an informative and entertaining talk geared towards members of start-ups or those keen to pursue regulatory affairs as a career. He covered various aspects of regulations in Asia and shed light on the most relevant resources for regulatory information, as well as the qualities of a good regulatory professional. This event was moderated by Dr. Sowjanya Kallakuri, who facilitated a lively discussion at the end featuring many questions by attendees. A recording of this webinar can be found here.

 

The second webinar titled “The American Chapter: Managing Quality Issues in FDA Regulated Industry” was given by Dr. Ratnakar Joysula, Associate Director from Pfizer Global Regulatory affairs USA, on June 16th and moderated by Dr. Angad Rao. Dr. Joysula has several years of experience in FDA regulations and his talk focused on managing FDA and global regulatory requirements in the context of managing quality issues.  He spoke about how to perform root cause analysis, set up a corrective and preventive action plan (CAPA) plan and evaluate the effectiveness of the CAPA plan.  Many participants indicated that they found this very helpful for answering technical challenges that they were facing. The slide deck of this webinar can be found here.

 

The third and final webinar in this series titled “The European Chapter: Essentials of the New EU Medical Device Regulation” was given by Dr. Arkan Zwick on July 7th and moderated by Dr. Debleena Ray. Dr Zwick is an expert on the EU regulatory system and the director of regulatory affairs at Croma Pharma in Austria. His talk addressed hot topics in the EU medical device regulation (EU MDR) and outlined strategies and timelines that can be applied by the medical device industry to transition into it. Importantly, this talk gave participants a clear understanding of EU MDR 2017/745 and its impact on the MedTech market as well as industry and notified bodies. The recording of this webinar can be found here.

 

Overall, the workshop series was a success and saw active participation from over 100 attendees in each webinar. We also received positive feedback on this series, with attendees saying that they learnt a lot, especially those who were considering a future career in regulatory affairs.

Key takeaways from this workshop series-

  • Engage a regulatory affairs personnel/consultant early on for smoother/quicker approvals.
  • Soft skills like stakeholder management are critical for aspiring regulatory professionals
  • Adopt and integrate a GCP CAPA management within the quality system of an organization to gain more confidence in clinical study data.
  • MedTech Industry should focus on renewal of their MDD licenses to assure continuity of market authorizations by 2024.
  • Product classification needs to be re-assessed based on MDR 2017/745

Biotech Connection Singapore (BCS) is part of an international network of non-profit organizations, that aims to promote the transfer of ideas from theory to real world applications by providing a platform for fostering interaction between academia, industry and businesses.

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