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Mar 3, 2016

Oliver Hellstern, MD joins Widler & Schiemann
Oliver Hellstern, Expert in Drug Safety, joins Widler & Schiemann Ltd. on March 1st, 2016

Oliver is an MD and Drug Safety Expert with over 15 years of experience at various companies and institutions. He has worked in Industry, the United Nations, the World Health Organization and the Swiss Regulatory Body SwissMedic. Oliver brings to our firm a wealth of experience in the field of Drug Safety and we are confident that our clients will benefit from his knowledge, experience and leadership.

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FDA issues new Guidance on Safety Data in late Stage Trials
Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations

This guidance is intended to help sponsors determine the amount and types of safety data to collect during late-stage premarket and postapproval clinical investigations, (e.g., phase 3 clinical trials, studies of new uses, long-term outcomes). This guidance discusses a selective approach to safety data collection during late-stage premarket development or during the postapproval stage based on what is already known about a drug’s safety profile. This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug. In addition, this guidance provides information to sponsors about consulting with the relevant FDA review division or divisions to determine whether a selective approach to safety data collection would be appropriate.

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EMA publishes Drug Safety related Draft Guidance for Consultation
Guideline on Good Pharmacovigilance Practices (GVP) 3 - Module V – Risk management systems (Rev 2)

Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This first major revision clarifies the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.

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Draft Guidance on format of the Risk Management Plan (RMP) in the EU – in integrated format
The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers.

The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focussed risk management system and simplifying the way information is submitted to the regulators.

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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -