Frank Schippers

Frank Schippers

$130/hr
Clinical development and pharmacovigilance
Reply rate:
-
Availability:
Hourly ($/hour)
Age:
55 years old
Location:
Cologne, Nrw, Germany
Experience:
15 years
About

More than 15 years in the pharmaceutical industry on Sponsor side have established a good level of understanding regarding clinical development in all phases of drug development and life-cycle management / post marketing activities. Furthermore, a detailed knowledge of pharmacovigilance, incl. risk management, signal detection, periodic reports and single case management provides a solid background in adjacent fields.

The recent (and ongoing) experience in a mid-size CRO has added valuable insights into the service provider side of the business and has provided the first chances to use my Six Sigma skills in projects to improve the monitoring activities on-site, to implement a completely new aspect of monitoring (remote monitoring), and to establish elements of Risk-based Quality Management into the overall QM system of the company.

The involvement in various Health Authority interactions, such as Scientific Advise meetings with the EMA, pre-NDA, mid- and late term review meetings with FDA, PMDA and Health Canada have taught me to define an overall strategy, deliver the required documents as well as explain and defend the respective company position successfully versus the regulatory counterparts. The responsibility for PSURs, DSURs and RMPs as well as contributing the clinical efficacy and safety modules to successful FDA, EMA and PMDA New Drug Application dossiers completes my experience re. the most relevant sort of interactions with regulatory agencies.

This sound experience comes on the basis of a structured and well organized educational program in general anesthesia at university level, which comprised in-depth knowledge of clinical anesthesia, intensive / acute care and emergency medicine as well as pain therapy. After my board certification, I focused on Intensive / Acute Care and Emergency Medicine and was in charge of the entire anesthesia, intensive care and acute pain services during on-call shifts.

Based on this experience I still continue working as a consultant (as much as time allows) in order to keep my clinical skills and knowledge up-to-date.

Being in charge of teams with or without line management, presenting in front of an auditorium and writing scientific papers has been part of my entire working history and I feel comfortable and well equipped to take on new challenges on a national or international level as leading member of a strong team or as freelance service provider.

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