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Jul 2, 2020

Widler & Schiemann GmbH Germany Goes Live with Dr. Andreas Fischer, Managing Director
On 1 July 2020 Widler & Schiemann AG Announced New German Subsidiary.

We are extremely proud to be able to announce the founding of our German subsidiary, Widler & Schiemann GmbH, based in Drolshagen, Germany, located in the broader Cologne area. We are equally proud that Dr. Andreas Fischer has decided to join us and take over the management of our German subsidiary. Dr. Fischer is a chemist by training and has over 25 years of professional experience from the CMO and management consulting industry. His specialty is in all areas of IMP management and manufacturing. We are excited about expanding Widler & Schiemann into Germany and look forward to exploring the new opportunities and discoveries that lay ahead.

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Pharmacovigilance Inspection Program Risk Assessment Survey
On 30 June 2020 the Australian TGA announced that the PVIP Risk Assessment Survey is open for medicine sponsors to complete.

The Australian Therapeutic Goods Administration's (TGA) PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance processes, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritize and schedule pharmacovigilance inspections (please refer to the full guidance on pharmacovigilance inspections to learn more about the TGA's approach to prioritizing inspections).

Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score.

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Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials
On 29 June 2020 the EMA announced the availability of this guidance.

The Biostatistics Working Party (BSWP) would like to acknowledge the impact of the Coronavirus disease (COVID-19) on trial participants as well as on the resulting measures taken to address the COVID-19 pandemic on methodological aspects of ongoing trials. It is foreseeable that the COVID-19 pandemic will interfere with the conduct of many ongoing trials, not limited to just the collection, analysis and interpretation of clinical trial data.

BSWP would encourage Sponsors to take these points into consideration and to seek Scientific Advice on these matters early in the process if substantial modifications to the original protocols are considered necessary. Sponsors should also be assured that the aspects related to impact on recruitment, data collection, analysis and interpretation of results will be thoroughly reflected upon during the assessment of affected clinical trials data submitted to EMA for Marketing Authorization Application.

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Risk Evaluation and Mitigation Strategies: Modifications and Revisions
On 29 June 2020 the FDA announced the availability of the final guidance for industry.

This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS. Specifically, this guidance provides information, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on what types of changes to REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS (changes that may be implemented following notification to the FDA). This guidance is issued pursuant to section 505-1(h)(2)(A)(ii), (iii), and (iv) of the FD&C Act and section 1132(c) of Public Law 112-144.

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Review and Update of Device Establishment Inspection Processes and Standards
On 26 June 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to comply with section 702(b)(2) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs the FDA to issue guidance that specifies how the Agency will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic device establishments. FDA updated processes and standards as needed to address the new provisions in section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a) and to establish a standard timeframe for inspections. This guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers
On 22 June 2020 the FDA published the final guidance on the Q&A for industry and FDA staff.

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.

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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
On 19 June 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding:

  • Manufacturing controls to prevent contamination of drugs
  • Risk assessment of SARS-CoV-2 as it relates to drug safety or quality
  • Continuity of manufacturing operations

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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
On 17 June 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to provide recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments. The guidance outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

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Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
On 16 June 2020 the FDA announced the availability of the final guidance for industry, FDA staff, and other stakeholders.

This guidance is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.

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Widler & Schiemann AG - Baarerstrasse 75 - 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 - -