Toxicology and Biosafety

ID1001

Senior RA Expert

DVM, PhD, MBA, Royal Veterinary and Agricultural
Available for: Tasks

Competences

  • Regulatory toxicology and product safety.
  • Biological Evaluation Report.
  • Clinical Evaluation Report.
  • Medical Writer.
  • Biological Evaluation Plan and testing strategy.
  • Toxicological exposure and safety assessment.
  • Regulatory compliance for industrial chemicals, biocides and medical devices.
  • Planning, execution and evaluation of biocompatibility and chemical characterization studies.
  • Risk/safety assessment of chemicals, impurities, migrating substances etc.
  • Specialist in toxicology and development of new medicines and biotechnological products.
  • Publication of more than 60 peer-reviewed papers.
  • Scientific writer/medical writer experience.

Key results

  • Head of department of a group of 30 toxicologists.
  • Development of toxicological courses at post graduate level.
  • Submission of several non-clinical reports to authorities.
  • Head of Danish group for development of ISO standards for safety evaluation nanoparticles.
  • Danish representative at advisory board for EFSA.
  • Preparation and leadership to ensure marketing of consumer products to markets in EU and USA.

Regulations/Standards

Extensive knowledge in:

  • ISO 10993 for biosafety of medical devices.
  • Toxicological support for material selection or substitution projects.
  • ICH guidelines for non-clinical testing for safety of biotech, pharma, medical devices, food and feed
    ingredients and foods.
  • International submissions and approvals in: EU (EMA, EFSA, ECHA), FDA, Health Canada, China.

Personal Characteristics

Is a pragmatic, enthusiastic, extrovert, resourceful, constructive and straight forward person that believes in an open and honest dialogue, and enjoys working with others.

He has many years hands-on experience in Regulatory Affairs in relation to the non-clinical area and has been working with many different products.

He spends his free time with family, friends, biking, running and reading novels.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com