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May 4, 2020

Welcome Dr. Axel Thiele to join Widler & Schiemann AG as Associate Partner
In April 2020 Dr. Axel Thiele joined Widler & Schiemann AG as Associate Partner. His joining strengthens our expertise in Pharmacovigilance.

Dr. Axel Thiele has more than 30 years of professional experience in the field of Pharmacovigilance. He is former Director and Professor at the Federal Institute for Drugs and Medical Devices in Germany (BfArM) and Head of the Unit Risk Management Procedures and Pharmacovigilance Inspections.

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New Branch of Widler & Schiemann AG in Germany
Widler & Schiemann AG announced Dr. Andreas Fischer will join as Managing Director for their new German affiliate opening on July 1st this year.

Dr. Andreas Fischer has over 22 years professional experience from the CMO and consulting industry in all areas of IMP management, GMP quality management, (CMC) project management, outsourcing and vendor management and business development. Thereof, 2.5 years with Fisher Clinical Services Switzerland (Project Management & Business Development), 4.5 years with PricewaterhouseCoopers (PwC) Switzerland (R&D consulting) and more than 15 years as Managing Partner of a niche consultancy on IMP management with strong focus on strategic, operational and regulatory topics ensuring GMP compliance within IMP manufacturing. Active as GMP auditor since many years. His joining strengthens our expertise in the GMP field.

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International Compilation of Human Research Standards 2020 Edition
The Office for Human Research Protections U.S. Department of Health and Human Services compiled the 2020 edition of the international compilation of human research standards.

The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as “standards”) that govern human subject protections in 133 countries, as well as standards from a number of international and regional organizations. First published in 2005, the Compilation is intended for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research protections around the world.

Most of the listings provide hyperlinks to the source document. These laws, regulations, and guidelines are classified into nine categories:

1. General, i.e., applicable to most or all types of human subjects research

2. Drugs and Devices

3. Clinical Trial Registries

4. Research Injury

5. Social-Behavioral Research

6. Privacy/Data Protection

7. Human Biological Materials

8. Genetic

9. Embryos, Stem Cells, and Cloning

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Union Procedure on the Follow-up of Pharmacovigilance Inspections
On 30 April 2020 the EMA published this guideline effective 1 May 2020.

According to Article 19 of Regulation (EC) No 726/2004 and Article 111 of Directive 2001/83/EC, the competent authority of a Member State where medicinal products are authorised, in cooperation with the European Medicines Agency (hereinafter 'the Agency'), shall ensure that the legal requirements governing medicinal products are complied with by means of inspections. The competent authority may inspect the premises, records, documents and pharmacovigilance system master file (PSMF) of the marketing authorisation holder (MAH) or any firms employed by the MAH to perform the activities described in Title IX of Directive 2001/83/EC.

After every inspection, the competent authority is required to report on whether the MAH complies with the requirements laid down in Title IX of Directive 2001/83/EC and the content of those reports shall be communicated to the inspected entity. According to Article 111(8) of Directive 2001/83/EC, if the outcome of the pharmacovigilance inspection is that the MAH does not comply with the pharmacovigilance system as described in the PSMF and with Title IX of Directive 2001/83/EC, the competent authority of the Member State concerned shall bring the deficiencies to the attention of the MAH and give him the opportunity to submit comments, and shall also inform the other Member States, the Agency and the Commission. Any non-compliance identified should be rectified by the MAH in a timely manner through the implementation of a corrective and preventive action (CAPA) plan.

Some pharmacovigilance inspections will require significant follow-up and management due to the nature of the findings identified. Regulation (EC) No 658/2007 empowers the Commission to impose financial penalties on the holders of marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, and Article 111(8) of Directive 2001/83/EC states that, where appropriate, the Member State concerned shall take the necessary measures to ensure that a MAH is subject to effective, proportionate and dissuasive penalties. A variety of enforcement and infringement options exist within the Member States and are not further described in this guideline.

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Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic
On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.

The guidance is available for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. This updated guidance (version 3) provided additional flexibility and clarification on:

  • the distribution of medicines to trial participants. This takes into account social-distancing measures and possible limitations in trial site and hospital resources;
  • the remote verification of source data (SDV) in the context of social distancing measures. This aims to facilitate activities that support the approval of COVID-19 and other life-saving medicines;
  • notifying authorities of urgent actions taken to protect trial participants against an immediate hazard, or of other changes taken to support patient safety or data robustness.

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eCopy Program for Medical Device Submissions
On 27 April 2020 the FDA issued the updated version of the guidance for industry and FDA staff providing clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.

The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions. Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), requires the submission of eCopies with the issuance of this final guidance. This guidance describes how the Food and Drug Administration (FDA) is implementing the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.

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EMA updated EudraVigilance Registration Manual
On 23 April 2020 the EMA published the updated EudraVigilance registration manual.

The EudraVigilance XCOMP registration process has been integrated with the EMA Identity and Access Management (IAM) system. This means that the same self-service process MAHs, NCAs and sponsors currently use to manage user access and maintain accurate data on their organisation is now available for the XCOMP test environment.

In the updated manual the EudraVigilance XCOMP (Test system) has been aligned with Production. For more detailed information on the EV XCOMP registration process, please refer to Section 7 of this manual.

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Detailed Guidance on ICSRs in the context of COVID-19
On 21 April 2020 the EMA published the detailed guidance on ICSRs associated with medicinal products used for COVID-19 infection.

This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO.

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Fighting the Coronavirus together with the Corona Science App
On 15 April 2020 the Coronavirus Science App developed by Bern University of Applied Sciences and MIDATA was launched to fight the coronavirus together.

The aim of the Corona Science project is to make available as quickly as possible a collection of anonymized/aggregated health and symptom data in a semantic standard defined with eHealth Suisse as Open Data.

At present, people stay at home whenever possible and are asked to only contact doctors or emergency rooms when necessary. As a result, many people are not tested for COVID-19 and the actual number of people who fall ill is unknown. This free app will help to obtain better data in this situation. It will also provide a basis for monitoring the situation when the measures can be relaxed again.

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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 - -