Experience

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  Vrije universiteit brussel, belgium

  Jan 2002 - Jan 2007

  Predoctoral researcher
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  Kuleuven, belgium

  Feb 2008 - Jan 2009

  Postdoctoral researcher
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  Covington & burling, llp

  Feb 2009 - Oct 2015

  Regulatory & scientific advisor

  As a non-lawyer, I provided regulatory and scientific advice to life sciences clients.I assisted clients across several sectors, including pharmaceuticals, food, feed, cosmetics, chemicals, and medical devices. I drew on my unique technical and regulatory experience to help clients gain a competitive advantage in regulatory proceedings and strategic planning, especially where a firm understanding of the science is important. Key areas included orphan market exclusivity and data exclusivity aspects, such as the new chemical entity status, and borderline issues. I also advised on the regulatory requirements for food supplements and functional foods. I also had deep expertise on claims substantiation and on the Nutrition and Health Claims Regulation. Finally, I also advises on the rules on clinical trials and regulatory due diligence. Representative Matters· Successfully guided an American biotech company through the EU orphan designation procedure for two advanced therapy medicinal products (cell-based cancer therapy). · Worked with a specialized pharmaceutical company to overcome the European Commission’s policy opposition to a marketing authorization for an orphan medicinal product.· Helped a functional food company to challenge a Commission’s decision and underlying scientific opinion authorizing a competitor’s disease risk reduction health claim.· Provided on-going regulatory support to companies marketing functional foods and cosmetics in the EU, in particular in Belgium and Poland. Show less

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  Msd europe

  Nov 2015 - now

  Therapeutic area: Vaccines and Infectious Diseases (VID)People manager for a team of Regulatory Affairs Liaisons/Associate Liaisons responsible for pediatric vaccines: since Feb 2021• Provides EU regulatory expertise during development of medicinal products in the area of infectious diseases, including orphan designated products and vaccines. Contributes to regulatory submissions and Agency negotiations on pre-approval and post-approval milestones.• Internally recognized as a knowledgeable Subject Mater Expert on Orphan Designations and Orphan Medicinal Products (OMP), who provides strategic and procedural advices on orphan designation-related aspects across internal portfolio and who externally participates into policy initiatives by representing the company in EFPIA/Europa Bio OMP Joint-Task Force since 2017 and in Eucope OMP workstream. o Strongly contributed to an EMA piloting of a new submission portal, IRIS, for orphan designation-related procedures by participating to the pilot, providing valid comments, attending calls with the Agency prior and post-implementation of the portal. Show less Therapeutic area: Infectious Diseases (ID)• Contributed to market approval under accelerated assessment of an orphan medicinal product in the infectious disease area in the EU and Switzerland by internally supporting all milestones of a Marketing Authorization Application submission and assessment, through collaborating cross-functionally internally and through facilitating company negotiations with Agencies and assessors. Continuously provided clear guidance internally and led external discussions with the EMA and COMP to a positive outcome of orphan designation confirmation by the Agency;• Developed regulatory strategy for successful modifications of agreed pediatric investigation plans (PIP) for two medicines. Involved in internal planning with a goal to extend therapeutic indications and market new pediatric formulations in the EU;• Provided regulatory guidance and training to cross-functional teams and across pipe-line on aspects related to orphan designation and market exclusivity for new products and products in life-cycle. • On company behalf,o actively contributed to EFPIA/ EuropaBio and EUCOPE discussions on a Commission’s revision of Regulation 847/2000 regarding the concept of similar medicinal product in 2016. Provided and successfully defended specific wording put forward to the Commission by the trade associations;o through internal collaboration; developed and provided comments on the Commission’s revision of the Commission Notice on Regulation 141/2000 on orphan medicinal products. Show less

  • Senior Director, Regulatory Affairs Europe

    Jun 2022 - now

  • Director, Regulatory Affairs Europe Liaison

    Jun 2018 - Jun 2022

  • Associate Director, Regulatory Affairs Europe Liaison

    Nov 2015 - May 2018
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  Efpia - european federation of pharmaceutical industries and associations

  Sept 2018 - Jun 2019

  Project manager, science policy and regulatory affairs

  A part time professional secondment at EFPIA, in the Science Policy and Regulatory Affairs team• Successfully coordinated and facilitated delivery of two EFPIA Regulatory Strategy Committee-sponsored projects, the Evidence REVEAL study (Research to Evaluate and Validate Evidence Acceptance Levels from Real World Data and Complex Clinical Trial Designs) and a Legal and Regulatory analysis around innovation in medicine development and approval, in collaboration with external (legal) consultants, EFPIA member companies and in line with EFPIA policies.• Effectively supported an EFPIA staffer on reporting projects milestones and deliverables to the Regulatory Strategy Committee, the EFPIA Innovation Board Sponsored Committee and to the EFPIA Board. Show less