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Oct 1, 2015

Cheaper Generics for poor Countries
European Commission backs bypassing drug patents for poor nations

The European Commission backs the push by least developed countries to get access to cheaper generic drugs with an indefinite exemption from World Trade Organization intellectual property rules. The carve-out, being debated in the WTO, lets select countries import or produce generic medicines, regardless of patents. “It means producers of generics and international programs can supply drugs like HIV treatment in affected countries without fear of patent infringement suits,” the Commission said in a statement. The WTO granted a temporary exemption to a group known as “least developed countries.” The measure now moves to the Council, which needs to determine the EU’s position in the WTO Special Council on Intellectual Property. That body is expected to make a decision on the indefinite exemption issue at a meeting on October 15 to 16.

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Workshop on Risk-based Monitoring
Artem Andrianov and Peter Schiemann to lead workshop at PCT Conference in November in Hamburg, Germany

Artem Andrianov, Managing Director at Cyntegrity and Peter Schiemann, Managing Partner at Widler & Schiemann will lead a workshop at the Partnership in Clinical Trials Conference taking place in Hamburg, Germany. The workshop will be held on Tuesday, November 17th, 2015 and will answer a number of questions that come up repeatedly when planning and implementing an RbM approach. Peter and Artem will be joined by Aldir Medeiros Filho, Senior Data Quality Reviewer, Data Sciences Department at Mitsubishi Tanabe Pharma Europe and Adam Baumgart, B.Sc., CPM, Director, Process Excellence, Business Lead, Risk-Based Monitoring at Covance.

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Free Webinar on Implications of ICH E6 Amendment
In a webinar on October 20th, 2015, Clinerion and Widler & Schiemann will explain the implications of the ICH E6 Amendment on Managing Clinical Trials

The ICH has decided to modernize its approach to GCP in order to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.

In this webinar you will receive a preview of what modern GCP will contain and its likely impact on your organization, advice on how to prepare for its arrival as well as a demonstration of risk-based study oversight technology.

For those of you who can't wait, here is a sneak preview of some of the components of the modern GCP approach:

  • Quality Risk Management and Quality-by-Design Processes: Assessing risks specific to a study design and protocol
  • Risk-based Monitoring: Focusing on critical study elements
  • Risk-based Study Oversight Technology: Leveraging clinical and operational data

The webinar will take place on Tuesday, 20 Oct 2015, 10-11 am EDT (4-5 pm CET).

Sign up here:

Read more online

FDA issues draft on Protection of Human Research Subjects
This draft guidance is open for comments for the next 60 days.

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.

Summary (includes link to PDF): Read more online

Notice of Proposed Rulemaking (NPRM): Read more online


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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 - -