Overview
Work History
Education
Publications
Conferences
External Presentations Delivered
Internal Training Delivered
Memberships
Volunteering
Certification
Languages
Timeline
Generic
Laura Caneva

Laura Caneva

Regulatory Affairs Manager
Brussels,BRU

Overview

12
12
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Manager

Zoetis
06.2019 - Current

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 - Unilever (2016), Netherlands;
  • 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

Uppsala University

MSc - Analytical Toxicology

King's College London

BSc (Honours) - Biochemistry

University of Edinburgh

European Baccalaureate -

European School of Luxembourg
Laura CanevaRegulatory Affairs Manager