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Apr 8, 2016

 
Pharmacovigilance Training
Widler & Schiemann offer a two-stage Pharmacovigilance Training lead by Dr. Oliver Hellstern, PV expert at Widler & Schiemann

At Widler & Schiemann we offer a new comprehensive two-stage Pharmacovigilance Training.

Stage 1 is a basic training, designed for all staff of a sponsor or Market Authorization Holder (MAH) to meet the regulatory requirements, which all company employees have to be trained on for their individual Pharmacovigilance obligations. The training provides a basic knowledge on how to identify and report suspected Adverse Drug Reactions.

Stage 2 is an advanced training to provide profound knowledge of all the aspects of Pharmacovigilance. It is designed for employees who have interfaces with Pharmacovigilance, i.e. Regulatory, Clinical or Marketing, etc, and training of new Pharmacovigilance staff members.

The benefits of Pharmacovigilance Training are much broader than just being aware of reporting responsibilities and identifying possible Adverse Drug Reactions. Having your employees trained in Pharmacovigilance you make sure you are

  • Meeting regulatory requirements,
  • Protecting your patients,
  • Keeping your stakeholders, i.e. physicians and other health care professionals, informed,
  • Protecting your business,
  • Avoiding lawsuits,
  • Avoiding negative press reports
  • Able to show the competent authorities (e.g. in case of an inspection) that you take Pharmacovigilance seriously

and - specifically for the advanced training - you improve the interfaces in your company and enable people working together more efficiently.

Take care of your Pharmacovigilance obligations!

Visit our website for more information and check out our detailed training agenda:

Read more online



FDA and NIH issue Draft Protocol Template
FDA and NIH jointly developed a protocol template for clinical trials which is now available for comments

The FDA and NIH have issued a draft clinical trial protocol template, which they jointly developed. Comments are being accepted until April 17, 2016.

“Enhancing important efforts around clinical trials continues to be a key scientific priority. Another way we can encourage clinical trials is to look for ways to help clinical investigators make clinical trials more efficient, potentially saving development time and money. Today we’re announcing a draft clinical trial protocol template developed by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) that should help with that.” Says Peter Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research

Read more online (FDA)
Read more online (NIH)



FDA issues Draft Guidance on Labeling of Biosimilars
Comments are being accepted during April and May 2016

From the Introduction of the Guidance: “This guidance is intended to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). Specific labeling recommendations for interchangeable biological products are not provided in this guidance…”

Read the pdf



Highlights form the EMA Management Board Meeting
The EMA Management Board met on 17th March in London

Highlights:

  • Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Devices Agency, elected as new chair of the Management Board
  • Pharmacovigilance Risk Assessment Committee (PRAC): Endorsement of draft rules of procedure on the organization and conduct of public hearings.

Read the pdf

 

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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 - info@wsqms.com - http://www.wsqms.com