article thumbnail

MHRA Chief Executive to step down

European Pharmaceutical Review

Her educational background includes training in medicine in Oxford after completing a master’s degree by research in Pharmacology. In 2012, Dame June was elected as the first chair of the European Pharmacovigilance Risk Assessment Committee, MHRA added.

Safety 111
article thumbnail

How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Our research looked at products that were voluntarily withdrawn, or had their licence revoked or suspended within the EU for a safety reason between 2012 and 2016. The Human Medicines Regulations 2012, UK statutory instruments, 2012 No 1916, PART 5, Revocation, variation and suspension of marketing authorisation. Study focus.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 Lane S, Lynn E, Shakir S.

Medicine 116
article thumbnail

How Banks and Credit Unions Are Getting Serious About Culture Change and Employee Engagement

Integrity Solutions

While focusing on culture is a step in the right direction, changing the culture isn’t as simple as putting people through a training program. Why Isn’t Training Enough To Drive Culture Change? The problem is that many organizations view the training itself as a catalyst for culture change.

article thumbnail

The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape

Pharmaceutical Representative Training

Non-Compliance CASE 3 : Case Summary: In 2012, another company paid a record $3 billion to settle charges of illegal promotion of prescription drugs, failure to report safety data, and false price reporting. The settlement was the largest healthcare fraud settlement in U.S. link] Department of Justice. link] Reuters. link] The Guardian.

Sales 52
article thumbnail

Tributes as former NICE, MHRA chair Sir Mike Rawlins dies

pharmaphorum

A pharmacologist by training, Rawlins was the founding chairman of health technology assessment (HTA) agency NICE , leading the organisation from its inception in 1999 until 2013, and hired Sir Andrew Dillon to become the organisation’s founding chief executive.

article thumbnail

Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

Dr Tanimoto earned an MD from University of Toyama, followed by internal medicine training at the National Center for Global Health and Medicine in Tokyo. World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. Prior to Pacific-Link Regulatory Consulting and Research, Inc., Hand (N Y). 2007; 2(1):5-11.