Veterinary Medicines Research & Development Department
Submission of Marketing Authorization Applications for veterinary medicinal products to the European Medicines Agency (EMA);
Management of the EU Artwork team (4 direct reports, 2023-2024): ensuring compliance of the SPC, label and Package Leaflet of veterinary medicinal products with the new EU Veterinary Medicines Regulation [Regulation (EU) 2019/6];
Maintenance of EU marketing authorizations e.g variations and renewals in compliance with EU, non-EU, and relevant regulatory requirements in Africa and Middle East;
Provision of regulatory guidance and support for regional and global veterinary medicinal product development project teams;
Liaison with Regulatory CMC, Laboratory Sciences, Global Therapeutic Development, Commercial Development, Global Manufacturing, Project Management to drive regulatory activities;
Advocacy activities on animal welfare (3Rs) e.g EPAA
Senior Regulatory Affairs Specialist
Bayer
05.2017 - 05.2019
Supporting Genetically Modified (GM) product authorizations for food and feed import in the European Union;
Drafting GM product authorization dossiers for submission to the European Food Safety Authority (EFSA);
Addressing regulators' and European Commission questions throughout the lifecycle of the GM product;
Participating in advocacy activities through industry associations e.g European Association for Bioindustries (EuropaBio) and scientific organizations e.g International Life Sciences Institute (ILSI);
Participating in Biotechnology-related stewardship activities on an ad-hoc basis e.g teaching at university
Regulatory Toxicologist
Unilever
05.2016 - 04.2017
Global regulatory support to Unilever categories (home care, personal care, food/refreshments);
Classification and labelling according to GHS and CLP regulations;
Review of the safety of ingredients in consumer products
Analytical Toxicology Specialist
European Medicines Agency (EMA)
10.2012 - 04.2016
Human Medicines Division
Environmental Risk Assessment of medicinal products for human use (eCTD Module 1.6);
Peer-review of Non-clinical Assessment Reports of Marketing Authorization Applications (MAAs);
Liaison with Procedure Managers, Product Team Leads and externally with (Co -)Rapporteur(s) of national competent authorities (NCAs);
Participation in Pre-submission meetings with Applicants (pharmaceutical companies);
Scientific support to the Safety Working Party (SWP), Pharmacokinetics Working Party (PKWP), Pharmacogenomics Working Party (PGWP) and the Committee for Medicinal Products for Human Use (CHMP);
Projects: analysis of the role of pharmacogenomic biomarkers in personalized medicine, safety of phthalates as excipients in human medicinal products
Education
MSc - Analytical Toxicology
King's College London
06.2012
BSc (Honours) - Biochemistry
University of Edinburgh
06.2011
ERASMUS Exchange - Protein Structure and Function, Proteins and Drugs, Toxicology, Microbiology, Molecular Cell Biology
Uppsala University
06.2010
European Baccalaureate -
European School of Luxembourg
Luxembourg
06-2007
Publications
Mark T.D. Cronin, Nicholas Ball, Sonja Beken, Hans Bender, Ofelia Bercaru, Laura Caneva, Marco Corvaro, Richard A. Currie, Jeffrey L. Dawson, Paul Desert, Sylvia E. Escher, Antonio Franco, Amaia Irizar, Jyotigna M. Mehta, Vera Rogiers, Raphaël T. Tremblay, Carl Westmoreland, Gavin Maxwell, Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum. Regulatory Toxicology and Pharmacology, 144 (2023) 105483;
Visser, M., Walsh, K., King, V. Sture, G. Caneva, L. Acceptance of oclacitinib maleate (Apoquel) chewable tablets in client-owned dogs with allergic and atopic dermatitis. BMC Vet Res, 2022, 18, 103;
Alie de Boer, Lisette Krul, Markus Fehr, Lucie Geurts, Nynke Kramer, Maria Tabernero Urbieta, Johanneke van der Harst, Bob van de Water, Koen Venema, Katrin Schütte, Paul A. Hepburn, Animal-free strategies in food safety & nutrition: What are we waiting for? Part I: Food safety. Trends in Food Science & Technology, 2020, 106 (469-484);
Caneva L, Bonelli M, Papaluca-Amati M, Vidal JM. Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure. Regul Toxicol Pharmacol. 2014 Apr; 68(3):312-6;
Ehmann F, Caneva L, Papaluca M. European Medicines Agency initiatives and perspectives on pharmacogenomics. Br J Clin Pharmacol. 2014 Apr; 77(4):612-7;
F Ehmann, L Caneva, K Prasad, M Paulmichl, M Maliepaard, A Llerena, M Ingelman-Sundberg and M Papaluca-Amati. Pharmacogenomic information in drug labels: European Medicines Agency perspective. The Pharmacogenomics Journal. 2015 Jun; 15 (3), 201-210.
Conferences
12th World Congress on Alternatives and Animal Use in the Life Sciences 'Replace, Reduce, Refine - 3Rs Over the Edge', August 2023, Niagara Falls, Canada;
IUTOX 15th International Congress of Toxicology (ICT), 'Toxicology Solutions for Global Public, Environmental, and Personal Health', July 2019, Hawaii, United States;
IUTOX 14th International Congress of Toxicology (ICT), Toxicology and Global Sustainability (2016), Merida, Mexico;
The Role of Science in Environmental Decision-Making - SETAC Latin America 11th Biennial Meeting (2015), Buenos Aires, Argentina
External Presentations Delivered
Considerations for the Use of Animal Studies in the Risk Assessment of Genetically Modified Plants - ILSI Europe Workshop Holistic Approaches to Develop Alternatives for Animal Testing (September 2018), Brussels, Belgium
Agricultural Biotechnology - Department of Industrial Microbiology and Food Biotechnology, Vrije Universiteit Brussels, (November 2017 and October 2018), Brussels, Belgium
Internal Training Delivered
New EU Veterinary Medicines Regulation [Regulation (EU) 2019/6] - Zoetis (2021), Belgium;
Environmental Risk Assessment of Medicinal Products - EMA (2015), United Kingdom;
Non-clinical Drug Development - EMA (2014), United Kingdom.
Memberships
Belgian Society of Toxicology and Ecotoxicology (BelTox), 2018-2024;
Toastmasters International, 2016-2022. President (July 2019-June 2020), Secretary (2018-2019) and Vice President of Public Relations (2017-2018) of Club 05116931 (Brussels), Area B3, District 59. Competent Communicator Recognition (22 July 2018).
Volunteering
Membership and Adminsitration Advisor at ''Friskis&Svettis Brussels'' (September 2024-present)
As part of the"Administration and Memerbership" team I am responsible for the following tasks:
Ensuring timely payment of membership fees by volunteers and regular members
Troubleshooting payment issues in the online membership portal and of payments received through the organization's bank account
Providing members with invoices and health insurance forms
Keeping the employee database updated e.g. new and departing volunteers
Collaboration with other departments including the Board, the Communications team, the host coordination team and the schedule team
Helping the Board with the organization of the Annual General Meeting
Certification
Immuno-oncology therapies: safety assessment strategies (2018), Newcastle, United Kingdom. Certified by the British Toxicology Society (3 CPD)
Mixture Toxicity and Risk Assessment (2017), Liverpool, United Kingdom. Certified by the British Toxicology Society (3 CPD)
Ecological Risk Assessment and Causal Analysis in Environmental Decision Making (2015), Buenos Aires, Argentina. Certified by SETAC
Practical Application of Toxicology in Drug Development (2014), Edinburgh, United Kingdom. Certified by the American College of Toxicology and Charles River Laboratories
Languages
English
Bilingual or Proficient (C2)
Italian
Bilingual or Proficient (C2)
French
Upper intermediate (B2)
Dutch
Intermediate (B1)
Timeline
Regulatory Affairs Manager
Zoetis
06.2019 - Current
Senior Regulatory Affairs Specialist
Bayer
05.2017 - 05.2019
Regulatory Toxicologist
Unilever
05.2016 - 04.2017
Analytical Toxicology Specialist
European Medicines Agency (EMA)
10.2012 - 04.2016
ERASMUS Exchange - Protein Structure and Function, Proteins and Drugs, Toxicology, Microbiology, Molecular Cell Biology
EU Business Development Director at FIRST SOLAR, US Solar PV Modules ManufacturerEU Business Development Director at FIRST SOLAR, US Solar PV Modules Manufacturer