Anette Yan Marcussen has more than 30 years of experience in pharma, both in production and quality. She has an M.Sc. in Pharmacy and before that studied Pharmacology. She possesses profound and proven leadership and management skills as well as in-depth knowledge of GMP, quality assurance, quality control, aseptic production and quality intelligence.

Anette has worked with strategic development and has driven international projects of strategic importance. She has built a strong business understanding via her roles as employee-selected member of the Board of DAKO A/S and as joint owner of a contractor company.

Anette Yan Marcussen is also actively involved in multiple international associations, such as Chair of the Regulatory and Quality Advisory Board for the PDA (Parenteral Drug Association) and a member of the BioPhorums Annex 1 Workstream Group. Here the pharma industry discusses the interpretation and implementation of Annex 1 requirements.

What's your view on the industry?

"The pharma industry is about to undergo big changes to succeed with innovation, big data use, new technology and overcome the post approval change hurdle.

This can be done by close cooperation between regulatory authorities and pharma companies. I think it will be very important to work together as a team to benefit the patient."

Why do you work in this business?

"I work in the pharma industry because I want to contribute to innovation and bring new drugs to the market for the benefit of patients. To ensure this, it is very important to guard the license to operate by complying to authority regulations. The pharmaceutical quality system (PQS) is key to compliance and to have a flexible and agile company. Therefore, it is crucial to simplify the PQS and optimize the way we work."

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