Seminar 9 - Diary by William Chin

See here the agenda of this seminar

Freiburg, Oct 20, 2014 – My academic journey at EUCRAF has come to an end. Seminar 9 entitled “Good regulatory affairs practice: communication skills, project management and tools for the daily practise”, was held on the 09 – 11 October 2014 in Freiburg, Germany. This was the final of the 10 seminar series of the MSc in Regulatory Affairs for Biopharmaceutical. A total of 28 participants attended this seminar. As evident from the title, the theme of the seminar was all about understanding the communication process. Do we really need communication skills as a regulatory professional? Absolutely yes! Isn’t writing skills alone sufficient? Absolutely not! Apart from written communication, effective verbal communication is important to establish rapport between team members from various functions as well as during interaction with the regulatory authorities. This seminar taught us techniques needed for an effective communication. Besides that, we also learned about the function of regulatory intelligence and key aspects of document and project managements.

The night before the Scientific Advice meeting, the Company team was busy finalizing the slide deck and rehearsing till midnight.

I must admit that this final seminar was challenging because the final examination consisted of the preparation of a Briefing Package and presentation at the mock Scientific Advice meeting. At the previous seminar 8, we were divided into 2 teams - the Agency and the Company. The Company team was required to prepare a Briefing Package that was to be presented to the Agency team. We certainly did not take this exercise lightly. There was a whole month of research preparation followed by teleconferences and strings of emails, all happening in between our day job and travelling commitments. I am not exaggerating when I say that the Scientific Advice meeting is a discipline in its own right, which is both art and science. For example, one has to observe the code of conduct during the meeting; scenario preparation to address questions from regulators; who exercises the mandate for decision making; who is responsible for the meeting minutes and how to effectively state the company’s positions in that limited amount of face time with the Agency. On the night before the Scientific Advice meeting, both teams were busy preparing and rehearsing till midnight. Overall, the meeting went really well. As part of the evaluation, video recordings were taken during the meeting. Some of us are gifted to be exceptional speaker and presenter, while some of us (i.e. yours truly) are still work-in-progress. The outcome of this exercise was truly a unique learning experience and worth all the effort. We had a pre-graduation celebration hosted by EUCRAF at the elegant Winzerhaus Rebstock restaurant, known for its authentic regional gastronomy.

Class of 2013/214

When I ponder on my journey at EUCRAF started over a year ago, I have gained so much of knowledge and foster some friendship. I chose Regulatory Affairs as the next step for my career advancement as I wanted to challenge myself after 11 years of working in research laboratories. I have the pleasure to meet my fellow classmates who are also pursuing the same passion as I am. And EUCRAF has provided us with the training, knowledge and network needed to start a career in regulatory affairs. By now, all of us have landed a job in regulatory affairs. Some of our more established classmates even got a career promotion and some of us have had the opportunity to move on to a bigger role in another company. For this, I (and perhaps the others too) am thankful for the journey and opportunity that EUCRAF has provided.

William Chin completed the Master in Regulatory Affairs for Biopharmaceuticals at EUCRAF and previously obtained a Ph.D. in Biomedical Science from the Department of Pharmacy, National University of Singapore. He is now the Scientific Coordinator at EUCRAF and Consultant at Biopharma Excellence, a biopharmaceutical consultancy company based in Munich.