Ria Vos

Consultant Nonclinical Drug Development (Toxicology, ADME)

About

• 30 years of experience in nonclinical drug development • Background in both ADME and toxicology • Writing or review of nonclinical sections of CTD, IB/IMPD, PIP (pharmacology, ADME and toxicology) • Analysis or preparation of nonclinical development plans • Monitoring of ADME and toxicology studies • Products: chemical and biological entities, cell therapy and medical devices. • Therapeutic areas: reproductive medicine, CNS, cardiovascular, immunology, oncology, virology, dermatology, rheumatoid arthritis, pain management • Routes of administration: oral, intravenous, subcutaneous, inhalation, topical • Quality and timelines are top priority Specialties: • Advice on and review of nonclinical development plans • Preparation and review of nonclinical sections of CTD and other regulatory documents (pharmacology, ADME and toxicology)

Country

City

Netherlands

Industry

Pharmaceuticals

Skill

Toxicology, Pharmacology, Drug Development, Pharmacokinetics, Drug Metabolism, Oncology, Virology, GLP, Drug Discovery, ADME, Scientific Writing, Biotechnology, Dermatology, Pharmaceutical Industry, Immunology, Clinical Study Design, CRO, Clinical Development, Therapeutic Areas, Regulatory Submissions

Experience

Consultant Nonclinical Drug Development (Toxicology, ADME)

Admeritox

2004 - Present · 22 yrs

Nonclinical development strategy - Study design and monitoring - Scientific writing of nonclinical reports and regulatory documents

Groupleader Nonclinical Project Management

Organon

1997 - 2001 · 4 yrs

Responsible for nonclinical development plans (ADME, toxicology) and their implementation, associated budget and timelines. Monitoring of studies. Preparation and review of safety evaluations to support First-in-Human administration. Preparation of nonclinical sections of regulatory documents. Participation in interactions with regulatory authorities.