Senior Manager Regulatory Policy & Intelligence
Since April 2006
- Monitoring, implementation and shaping of the regulatory environment (legislations and specific/technical guidelines) at EU, and International levels (ICH, Japan and some emerging markets such as India, Taiwan, Vietnam, …). o Interpretation and assessment of the impact of new regulatory developments and trends on vaccines and on the Company’s business; o Preparation/coordination of comments, position papers, and advocacy strategies (as appropriate) on behalf of GSK Bio; o Active engagement in initiatives aiming at shaping the external regulatory environment o Advise the Company on regulatory strategies. o Support/Advise the adequate implementation of new regulatory requirements within the company - External Company representation and influence: o Direct contacts with relevant authorities: in EU (European Commission, EMEA), EU Member States (e.g. Belgium, Germany, France, UK, Netherlands), Japan (PMDA/MHLW) o External Advocacy Groups and Trade Associations (EFPIA, EVM, EuropaBio, PhRMA, ...) - Acting as EU champion within GSK Bio for any general EU regulatory procedural matters (EMA / Commission), and for coordination of GSK Bio portfolio meetings with EMA; - Acting as champion for Japan, and active involvement (project leader) in operation excellence initiatives to improve vaccine registration in Japan; - Active involvement (as lecturer and in organisational matters) in dedicated internal training programmes for RA colleagues and other relevant colleagues; - Tailor-made expert advices to RA colleagues, as well as other relevant colleagues as appropriate; - Support day-to-day vaccine registration activities in various new projects, e.g. influenza vaccines (seasonal and pandemic vaccines), therapeutic vaccine (anti-cancer immunotherapy), paediatric, adolescent and adult vaccines, third world vaccines, etc. - Internal dissemination/communication of intelligence within the company.
Deputy Head of the Scientific Technical and Regulatory Affairs Department
January 1993 --- November 2005
- Management/coordination of the industry advocacy/lobbying initiatives with respect to any issues and new developments with legal, regulatory and technical requirements related to the development, submission, authorisation and supervision of medicinal products in the EU; - Active involvement in industry initiatives to re-shape the EU regulatory environment; e.g. specific new EU legislations (Clinical Trials Dir., Variations Reg., New Pharmaceutical Medicines Legislation, etc.), and various EU and international (ICH) technical guidelines (CTD, GCP, GMP, Non-clinical and Clinical guidelines, etc.), - Direct interactions with relevant regulatory authorities at European and national levels (Commission, EMEA, CHMP, MSs), and political decision-makers (MEPs); - Official ICH Coordinator for EFPIA (European research-based pharmaceutical industry) in the international harmonisation process (ICH): active involvement in official negotiations among the different key ICH stakeholders (incl. European Commission, EMEA, US FDA, MHLW, PMDA Health Canada, SwissMedic, WHO, EFPIA, PhRMA, JPMA, Eur.Ph., USP, JP), and in global harmonisation discussions with regional harmonisation initiatives in non-ICH regions (APEC, ASEAN, PANDRH, GCC, SADC) - Management of official committees of pharmaceutical companies representatives and specialized industry technical expert groups; - Preparation/consolidation of comments, position papers, policies and advocacy strategies on behalf of the European pharmaceutical industry, and Representation of these positions in official meetings with authorities and other trade associations, as well as in public forums and conferences; - Preparation of public communications and press releases, and interactions with relevant patient associations, and external media and communication professionals; - Coordination and support to events and conferences at European and international levels.
May 1990 --- January 1993
Consultancy for a number of multinational clients (N.B. Registration activities covered various types of medicinal products, with particular focus on biologicals and vaccines. Clients included several leading pharmaceutical multinationals.). - Advice to clients. - Analysis, review and compilation of information and data for registration dossiers; - Preparation (writing) of Part II registration dossiers (CMC) and Expert Reports; - Submission and follow-up of applications to regulatory authorities in Belgium, France, Netherlands and Europe.
September 1987 --- August 1989
Laboratory Research (diagnostic methods, immunological, electrophoretic and genetic techniques).
Reserve Officer (Lieutenant)
May 1986 --- June 1987
Coordination of the laboratory work (team of 5) in the FSP Unit (i.e. Injectables Manufacturing Unit): human plasma freeze-drying and preparation of perfusion solutions.
MSc (Hons) in Molecular Biology from ULB (Université Libre de Bruxelles) in 1985
in from CERIA Oenologie) in 0