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March 27, 2014

 
Alcinda Aloe joins WSQMS as Partner
Alcinda’s vast experience is a great asset to broaden our service offering, says Dr. Widler, Managing Partner at WSQMS.

Alcinda has solid experience in multinational pharmaceutical industries (Wyeth, Roche and Novartis), having also advised angel investors / venture capital organizations across regional and global settings. Her experience includes CR&D, Global Clinical Operations, Innovation & Strategy and Strategic Alliance Management.
She successfully headed cross-functional, multicultural teams including professionals with advanced scientific degrees. Built and managed strategic relationships with academia, KOLs, medical communities of several therapeutic areas, CROs, regulatory bodies, as investors and other players of the life sciences ecosystem in different geographies.
As member of several global initiatives and global committees, optimized communication, practices and reshaped strategies. She is member of the judging panel of MIT (TR35 initiative) in several countries; the program partners with leading research and business universities around the world to select and award biomedical and technology innovations of high value and impact.

More details online



Latest update on EMA GVP – the new Pharmacovigilance legislation
EMA publishes update and planned next modules on GVP

The European Medicines Agency plays a key role in the safety monitoring of medicines in the European Union (EU) - this is known as pharmacovigilance. The Agency’s main role in this area is to support the coordination of the European pharmacovigilance system and to provide advice on the safe and effective use of medicines.

More details online



Memorandum of Dr. Margaret Hamburg, Commissioner FDA
Dr. Margaret Hamburg, commissioner FDA, publishes memorandum on the future role and focus of FDA.

The focus of the agency shall be getting up to speed with new developments.
The focus areas are:

  • Commodity-based and vertically integrated regulatory programs
  • Specialization of inspectorates and compliance functions
  • Training for FDA staff to achieve the necessary level of competence
  • Agency work planning and better utilization of resources
  • Further development and enforcement of compliance strategies
  • Import of products/commodities
  • Laboratory optimization
  • Moving from a geographically based model to a program based and functional model

Download the PDF



Updates to Good Clinical Practice section: 2010-2011 GCP inspection metrics report published
A report covering the period 1 April 2010 to 31 March 2011 has been added to the good clinical practice section

The report contains the analysis of 161 GCP inspections performed by the MHRA for sites in the UK only.

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Overview of comments received on ‘Reflection paper on the use of interactive response technologies in clinical trials
The EMA published recently all comments they have received on their reflection paper including their answers to questions.

16 interested parties had commented on the reflection paper. Among them pharmaceutical and biotechnological companies, but also international associations and interest groups.

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‘Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices’ for comments
FDA publishes revised draft guidance for comments within the next 60 days

This guidance describes the Food and Drug Administration’s current thinking on recommended practices for drug and medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States.

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MHRA and NHS England in initiative to simplify adverse incident reporting
Simplification addresses two topics: Medication Error & Medical Devices

MHRA and NHS England have jointly issued two patient safety alerts and supporting guidance to help simplify reporting and help healthcare providers increase incident reporting involving medication errors and medical devices. This work is the result of extensive stakeholder engagement and aims to increase the quantity and quality of adverse incident reports to both organisations. It will also enable us to provide effective and regular feedback to healthcare providers in order to promote patient safety.

More details online



EMA publishes its work programme for 2014
Legislative developments remain one of the main drivers of the Agency’s priorities this year.

The European pharmacovigilance legislation that became fully operational in July 2012 brought one of the biggest changes to the legal framework for human medicines since the creation of the Agency in 1995, and its implementation is still a significant area of activity for the Agency.
Among the priority activities in this area in 2014 are the further development of methods for collecting best evidence, enhancement of functionalities of EudraVigilance, the European database on adverse drug reactions, the development of a repository for periodic safety update reports (PSURs) as well as a system for monitoring the scientific literature for signal detection.
The Agency will also continue the implementation of the falsified medicines directive that came into force in 2013 and will closely monitor and contribute to the debate on new legislative proposals on the conduct of clinical trials and on veterinary medicines.
This year the Agency will also maintain its emphasis on support to the early stages of medicines development. This is an essential element in the Agency’s contribution to increasing the likelihood of new medicines reaching patients. The Agency’s efforts will focus on promoting the use and integration of existing tools in place to engage in early dialogue with medicines developers, such as parallel scientific advice with health technology assessment bodies or scientific advice in relation to innovative technologies. It will also support the development of new approaches and innovative medicines through the developing specific guidelines.
In 2014, the Agency will continue the work started in 2013 to reorganise its processes and structures in order to better support the work of its scientific committees, to better share knowledge throughout the European medicines regulatory network and to better meet the needs of its various stakeholders. The work will continue to improve the efficiency and effectiveness of the Agency’s operations so that it can continue to effectively conduct its core business activities to the highest level of quality and consistency in a rapidly changing environment.
The European medicines regulatory network is the cornerstone of the Agency’s work and success. In 2014, the Agency will enhance its cooperation with the national competent authorities of the European Union through training, expansion of national experts’ programmes and focusing on IT systems that deliver value to the network. The Agency will also implement a series of measures designed to improve the quality, integration and accessibility of data that it holds for the network and its stakeholders.

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