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ISAC Vacancies

ISAC is now looking for 8 professional members who will have strong track records in epidemiology, public health research, recent experience in UK Primary care or related research and the ability to develop an understanding of the UK/European medicines regulatory procedures.

Please click here for more information


Dr Janet Valentine appointed as new CPRD Director

TThe Medicines and Healthcare products Dr Janet Valentine Regulatory Agency is delighted to announce the appointment of the new director for The Clinical Practice Research Datalink (CPRD) Dr Janet Valentine.

Dr Valentine joins us from the Medical Research Council where she was Head of Population Health and Informatics. She has worked closely with the UK’s leading medical researchers for over a decade and her extensive knowledge of health research and use of health data for an array of clinical and public health applications will be invaluable in her new role.

Prior to this she was deputy chief executive of the UK Clinical Research Collaboration (UKCRC) working with the key stakeholders that shape clinical research in the UK.

CPRD, the secure electronic service providing anonymised health data for clinical research was launched three years ago and is jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). Clinical research enabled by CPRD continues to help accelerate the development of new treatments, and improve health services, drug safety and public health.

Its services capitalise on the population wide healthcare coverage provided by the NHS, maximising the way NHS clinical information is used for patient care and population health.

Dr Valentine said:

“There is a wealth of opportunities for drug development and patient care offered by clinical research based on anonymised NHS and health related data. I am delighted to join CPRD and look forward to building on the excellent healthcare outputs generated from CPRD data.”


Department of Health triennial review of arm’s length bodies

News

1 December 2014

The Department of Health (DH) reviews its arm’s length bodies once every 3 years.

This review is looking at what MHRA, the British Pharmacopeia and the Commission on Human Medicines do and how.

DH has sent out a public call for evidence to support the reviews.


FDA Commissioner to speak at MHRA Annual Lecture

The Medicines and Healthcare Products Regulatory Agency hosts an Annual Lecture for an invited audience including senior figures in medicine, government, academia and industry. It provides an opportunity to meet and network with staff, and hear from international experts on important issues in the wider societal context of medical product regulation and advances and challenges in science and research.

This year, the MHRA welcomes Dr Margaret A. Hamburg, who will be offering her perspective on an international theme around the challenges presented by globalisation over the next 10 to 15 years and the collaborative efforts of regulators internationally to respond. Dr Hamburg is the Commissioner of the US Food and Drug Administration (FDA) and has provided leadership in this field.

Dr Hamburg will cover six main themes in this year’s lecture:

  1. Challenges presented by globalisation over the next 10-15 years and the collaborative efforts of regulators internationally to respond to these
  2. Scientific collaboration between regulators
  3. Use of real world data
  4. Smart regulation in a changing world
  5. Challenges posed by rapid advances in science and technology and supporting innovation
  6. Importance of collaboration

Debate and discussion will continue at the drinks reception which will follow the lecture.


Updated CPRD ISAC Applications Guidance

TThe Guidance on the content of CPRD ISAC applications has been updated and can be found under the ISAC section of our website. A PDF copy is also available for download. Click here for more information


ISAC audit of publications

The ISAC will be undertaking an audit of all publications in 2013 which resulted from studies using CPRD data. The primary purpose of the audit is for ISAC to better understand the level of concordance between approved protocols and the resultant studies. The ISAC guidance on amendments to approved protocols is available under the ISAC section of our website.