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Oct 1, 2016

Further clarification on clinical trial data made public
HHS makes it harder for clinical researchers to avoid sharing trial data

HHS on 16th September 2016 finalized a rule that expands and clarifies what clinical-trial data legally needs to be made public. The goal is to help scientists, doctors and patients learn more about ongoing research and potentially ease access to experimental treatments.

A 2007 law required certain universities and manufacturers to report their results. But some exemptions and lax enforcement caused few to follow through. A Duke University study in 2015 found that only 13.4% of trials reported summary results within the mandated 12-month time frame following the end of a trial.

Read more online (Modern Healthcare) Read more online (NIH)

New CFDA Draft Regulation on Medical Devices
CFDA issues Quality Control and Product Release guidelines for devices for comments

The China Food and Drug Administration (CFDA)'s Medical Device Supervision Division has released a set of Guidelines for stakeholder feedback on "Medical Device Quality Control and Product Release". The aim is to guide medical device manufacturers in strengthening quality control across procurement, production, and inspection processes in accordance with technical requirements. Interested parties have until September 30, 2016, to issue comments or suggestions.

Quality control processes described by the Guidelines include checking, validation, monitoring, measurement, inspection and test activities and quality management covering main raw materials, parts and spare parts, intermediate goods and finished products, primary packaging materials, labels etc. These cover products, as well as all key and special procedures during production-related processes. The aim is to introduce standards drawn up with reference to U.S. FDA and international standards, as noted in accompanying explanatory comments.

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EMA Pharmacovigilance Draft Guidances
The European Medicines Agency has issued several PV Guidances for comments

Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2):

  • This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorization holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorized in the European Union (EU). Recommendations regarding the reporting of emerging safety issues or of suspected adverse reactions occurring in special situations are also presented in this Module.
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Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)

  • Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter III]. In this Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.
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Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

  • Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal detection. The monitoring process is facilitated by statistical summaries of the information received for each “drug-event” combination over defined time periods.
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CDER Small Business and Industry Assistance (CDER SBIA) Webinar
Study Data Standards in eCTD: What You Need to know about the New Technical Rejection Criteria - October 12, 2016

This 60 minute webinar will provide an update on FDA’s requirements for the submission of standardized study data in NDAs, BLAs, ANDAs and INDs. Further, the webinar will present the core set of technical criteria that will be the basis for technical rejection of applications that do not conform to the required study data standards.

Specifically, the webinar will address topics such as:

  • FDA’s electronic study data standards requirements in submissions
  • Exemptions to the electronic study data standards requirements
  • Understanding of the key validation criteria for the rejection of submissions not in conformance with the required study data standards
  • Consequences for failure to submit study data in conformance to the required study data standards
  • Study Data Technical Conformance Guide update on the use of Trial Design Model and Trial Summary Domain

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EDMS User Requirements – Pocket EDMS
A reference EDMS implementation protocol for small Pharma and Biotech

Pocket EDMS is a reference EDM implementation protocol for small sized companies. Pocket EDMS is based on a Universal Requirements Specifications set including, Users, System and Quality/Regulatory Requirements. It also includes a Q&A document (replacing the traditional RFI – Request for Information) and a set of notation tools allowing sponsor companies to easily evaluate vendor proposals.

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