On 1 July 2019, Anette Yan Marcussen will take up the role as Vice Chair of the PDA Regulatory Affairs and Quality Advisory Board. She will take up this role for the coming two years, after which she will become Chair for two years and then Past-Chair – also for two years. In this interview, she shares her ambitions for the coming six years as part of the advisory board leadership trio.
What are you most looking forward to as vice-chair and later chair and past-chair?
I was invited to be a member in RAQAB three years ago, and I have met so many very knowledgeable colleagues from all over the world. The benchmark and cooperation in PDA is truly valuable to all and help us drive the pharma business in an innovative direction. Also, I experience a close connection with authorities and mutual respect between PDA and FDA.
As vice-chair I am looking very much forward to working close together with the chair and past-chair, to set the agenda and influence the strategic direction for PDA, as well as interact with the FDA. Via discussions with highly competent colleagues in the industry, and formal as well as informal access to regulators in FDA, I am looking forward for us to clarify and simplify complex issues.
What is your ambition for RAQAB as a whole?
My overall ambition is to help drive a team of experts and foster a culture of clear communication and effective meetings and workshops. My goal for the board is to comment on and influence on new regulations in a positive and effective way. Part of this involves bringing up-front knowledge of new external authority requirements and decide on which to influence.
My goal for the board is to comment on and influence on new regulations in a positive and effective way"
And then I want to make sure that we continue to invite competent new members into RAQAB to strengthen the team and our influence on regulators.
How will you contribute to reaching that ambition?
Firstly, by being engaged and deliver my time and knowledge. And second by working closely with my chair members and PDA board of directors.
What experience do you bring to RAQAB?
More than 30 years of experience within pharma and medical device industry, both in production and quality. I will apply my profound and proven leadership and management skills and my in-depth knowledge of GMP, quality assurance, quality control, aseptic production, inspections/audits and quality intelligence.
Where do you see yourself in five years? How about the industry?
Hopefully much wiser! And being the past-chair for RAQAB, which I will be at that time, I hope that we have shown always to be up front on new regulations and trends in the regulatory environment.