regulatory affairs
Europe vs USA: New drug approvals
June 1, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NDA, regulatory affairs
Dr Terese Johansson, Regulatory Affairs Consultant NDA Group AB, examines the drop in US approvals while observing no similar trend …
Novo Nordisk appoints ex-Pfizer head
May 10, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Novo Nordisk, Pfizer, Robert Clark, regulatory affairs
Robert Clark will be joining Novo Nordisk as vice president, regulatory affairs. Clark will lead Novo Nordisk’s US regulatory team, …
EMA backs full access to trial data
April 12, 2012Business Services, Research and Development, Sales and Marketing EMA, clinical trial data, data disclosure, regulatory affairs, transparency
The European Medicines Agency says it wants to open up access to full clinical trial data, but warns that some …
Payment changes of authority’s fees in France
January 20, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates, regulatory affairs
Changes are being made in the way fees are paid for regulatory submissions and procedures in France. Fees are no …
FDA unveils changes to cancer drug review
September 14, 2011Research and Development, Sales and Marketing Cancer, FDA, regulatory affairs
The FDA has unveiled a reorganisation of how it reviews new cancer drugs, and says the new approach should help …
The growing role of regulatory affairs
June 30, 2011Business Services, Research and Development, Sales and Marketing regulatory affairs, topra
Some years ago, regulatory affairs (RA) was seen by some as merely a ‘front office’ function, providing a necessary interface …
European pharma’s compliance challenge
June 13, 2011Sales and Marketing global regulatory landscape, regulatory affairs, regulatory compliance
Life Sciences companies across Europe are facing a series of emerging global legislation and increased regulatory enforcement, designed to prevent …
Drug regulators protect profits over patients, new study finds
May 11, 2011Research and Development Bad Science, Vioxx, regulatory affairs
Medicine regulators are protecting drug company profits over the welfare of patients by withholding trial data. That’s the verdict of …
The Evolving Role of European Regulatory Agencies
January 26, 2011Research and Development Consultancy, regulatory affairs, regulatory agencies
The regulatory landscape can change in a very short period of time. Matthew Walker, Senior Regulatory Affairs Executive at TRAC …
Regulators must catch up with medical science, says FDA
November 2, 2010Research and Development, Sales and Marketing Advancing Regulatory Science, Critical Path Initiative’, Dr Margaret Hamburg, FDA, regulatory affairs
The head of the FDA has declared a need for ‘regulatory science’ to catch up with the advances in medical …
Shared API inspections project gains traction
October 26, 2010Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections
A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …
Conducting clinical trials in China
October 26, 2010Research and Development China, Jim Wei, Medpace, clinical trials, clinical trials in Chaia, regulatory affairs
As industry pressure to conduct successful global clinical trials on time and on budget continue, tapping emerging global markets will …
European medicines legislation and pharmacovigilance
October 20, 2010Research and Development NDA, pharmacovigilance, regulatory affairs
During the past decade, changes in European medicines legislation and guidelines have increased the scope and regulatory scrutiny of pharmacovigilance …
EMA: Aligning regulation with the lifecycle of medicines
November 30, 2009Research and Development EMA, EMEA, Thomas Lönngren, regulatory affairs
The European Agency for the Evaluation of Medicinal Products was set up in 1995 in London’s Docklands, an isolated eastern …
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