Risk Assessment and Risk Mitigation in Phase I Trials in High Risk Compounds: A Continuously Developing Process

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical, Preclinical,
  • Thursday, April 25, 2013 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

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Phase 1
studies typically have no therapeutic objectives and therefore the risk is not balanced by a potential benefit for the participating healthy volunteers or patients. Therefore it is essential the risk is minimized and that any unanticipated harm be rapidly detected and contained. Investigators should always strive to go that extra mile in ensuring volunteer safety, especially in compounds with higher safety risk. Valuable directions to ensure subject safety are given by for instance the 2007 EMEA guideline on identification and mitigation of Risks in First-In-Human Trials and the MHRA Phase 1 Accreditation Scheme.

The challenge is how to translate the guidelines into daily practice in a Phase I setting. New compound classes and design elements pose unique challenges to the risk mitigation process. Therefore the risk mitigation process is not only evolving within a single study but has to continue evolving as a whole.

Join our speaker for an in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA.


Thijs van Iersel, M.D., Senior Director of Scientific Affairs, PRA, Early Development Services, The Netherlands

Thijs van Iersel has over 20 years of experience in Clinical Development. He has been involved in the execution of Clinical Pharmacology studies as Investigator, in the design and clinical management of Clinical Pharmacology studies when employed by several Pharmaceutical companies, in developing a Phase I Clinical Pharmacology Unit and in GCP training for Investigators. In the previous years he was responsible for safety at the Clinical Pharmacology Units of PRA in the Netherlands. Apart from early clinical development, Dr. van Iersel has experience in clinical development of phase 1 to 4 studies including global clinical development, health economics and regulatory agency discussions.

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Who Should Attend?

This webinar will provide invaluable assistance to investigators and their staff in the considerations about safety in Early Clinical Development. Those benefiting the most would be:

  • Principal Investigators / Sub-investigators
  • Medical Directors
  • Program & Clinical Study Managers
  • Chief Medical Officers
  • Clinical Research Scientists (Pharmacokineticists, Clinical Pharmacologists)
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • QA / QC auditors and staff

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PRA’s global Early Development Services group can meet the needs of any Phase I study. We offer comprehensive services through our integrated bioanalytical laboratories, on-site pharmacies and clinical facilities in both Europe and the U.S. The strategic integration of our resources and expertise supports timely sample analysis and expedited decision making. PRA also operates an on-demand Phase I patient model in Central and Eastern Europe that brings the medical center to patients. In this model, physicians are able to recruit high volumes of patients through extensive networks of referring specialists and general practitioners.

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