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February 4, 2014

EMA Begins Publishing Names of GMP-Deficient Drugmakers
The list dates back to 2007

In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). The agency updated its EudraGMDP database to include the new noncompliance list, which currently includes 83 reports of GMP-deficient companies dating back to 2007.

Drug Industry Daily

Minutes of joint meeting of GCP IWG and eClinical Forum (eCF) representatives on electronic data capture systems and investigator site eSource readiness
Some challenges ahead for EDC

These Minutes do not offer any surprises and confirm requirements that have been known for quite some time. Nevertheless, the following statement, "It is essential that the principal investigator (PI) maintains an independent (i.e., out of the sponsor’s control), contemporaneous copy of the CRF for which he has exclusive control. This could be at the PI site, although, it could also be maintained at an independent site/vendor when assuring the investigator’s continuous access", could represent a challenge for those sponsors using an EDC system that is hosted on a sponsor's IT system and that does not allow to create a local copy of the data collected through the eCRF. Also the statement, "The responsibility for archiving and maintaining the CRF at the investigator site, regardless of whether it is paper or electronic, is the responsibility of the investigator and not the sponsor", is noteworthy, especially when an investigator does not have the infrastructure for the long-term archiving of its TMF and asks the sponsor for help. In such cases, the contract between off-site archiving company and the sponsor - this is what generally is implemented - must clearly state that only the investigator or his designee can ask for the retrieval of the TMF from the archives. The inspectors also pointed out that none of the EDC models presented meet the current regulatory requirements.

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Proposed changes to Directive 2001/20/EC
The European Commission, Parliament and Council published the proposal for repealing the Directive 2001/20/EC on "Clinical Trials on Medicinal products for Human Use"

The new EU Clinical Trials Regulation replacing Directive 2001/20/EC is now ready for EU Parliament Approval. The Regulation should make the EU a more attractive and competitive region to conduct clinical trials but will reality confirm this ambition? The fact that the Regulation grew into a 150 page ! document and that the approval timelines got extended from 60 days in the Draft document to 110 days, however, raises doubts about that ambition. When reviewing the new Regulation one gets indeed the impression that this document is rather the result of a compromise trying to integrate everyone's input rather than a coherent piece of legislation. This Regulation is unfortuantely another example of "legislation by committee" that results in a complex and long-winded document. In view of all the discussions about Quality by Design in Europe and US this is not a good start.

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Challenges, initiatives, best practice and the role of the pharmaceutical physician

ABPI as part of its ongoing efforts in promoting transparency around clinical trials and in helping to find practical solutions to the existing technical challenges organizes on March 25 together with BrAPP (British Association of Pharmaceutical Physicians) a masterclass event for all Pharmaceutical Physicians and their colleagues at the Royal College of Pathologists in London. We are proud to announce that Beat Widler of WSQMS will again be part of the faculty of this event.

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FDA Releases Social Media Guidance
Draft Guideline currently open for comments

FDA now requires companies participating in active ("real-time") discussions on Twitter, to submit information to FDA on a monthly basis, with a listing of all websites where company staff is actively contributing on behalf of their company. FDA said URLs to the firm's social media account would be sufficient so long as access to the sites remain unrestricted. In addition, sites controlled by third parties on behalf of the company will be subject to the same monthly reporting schedule. FDA will also need to be notified "on the first day the firm ceases to be active on a site. If a site is restricted, the firm should submit screenshots or other visual representations, also on a monthly basis.

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Payers Push Back Against Expensive New Medicines’ Costs
Another case where medicines are considered too expensive

Bloomberg News (1/27, Armstrong) reports that, with pharmaceutical companies developing “increasingly complex products,” Payers could see “billions of dollars in new drug costs.” The article focuses on Sovaldi (sofosbuvir), a hepatitis C cure by Gilead Sciences Inc. that costs $1,000 a pill. Already Express Scripts Holding Co., Catamaran Corp., Aetna Inc., and CVS Caremark Corp. are “pushing back against the” cost, saying they’re ready to block expensive medications from coverage. They also are considering pitting “similar drugs against each other,” requiring more review by outside experts, “and refusing to pay a premium based on one drug being more convenient to take than another.” Meanwhile, patients and advocates are concerned that such efforts to get patients to use cheaper medications first will force them to suffer side effects associated with cheaper treatments.

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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 - -