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September 19, 2013 | ISSUE NUMBER 317 VOL 11

Global
Crunch Time for Emerging Markets
Fading growth, overstretched governments, and a global governance backlash against pharma business are turning up the heat on the performance of emerging country markets, writes Pharm Exec Editor-in-Chief, William Looney ...Read more

Interview
Ever Bullish, Al Mann Says Afrezza is Coming in Mid-April
Post Exubera, inhaled insulin has been an uphill struggle with regulators. Al Mann
and Mannkind are nonetheless determined to push Afrezza, an "ultra" rapid-acting insulin, over the regulatory peak and into the market. Will it happen, or is Mann doomed to play Sisyphus on mount FDA?
...Read more

Video
Pharm Exec TV Goes Live
Pharm Exec’s growing library of video interviews with industry leaders can now be found on our new channel, PharmExec TV. Tune in for weekly updates and catch up now with the latest episode: the Center for Program Integrity at CMS ‘s Medical Director, Dr Shantanu Agrawal, on the implementation and impact of the Physician Payment Sunshine Act
...Read more

Smart Sourcing Strategy: A Whitepaper on Pharmacovigilance Vendor Selection
Strategic planning, sourcing and implementation of pharmacovigilance operations are multi-dimensional activities. There has been a considerable increase in the quality and quantity of safety processes being outsourced due to evolution of mature processes; risk mitigation strategies and increase in vendor experiences that has helped the sponsor balance core in-house strength and leverage the service provider’s capabilities. Learn how to adopt a Smart Sourcing Strategy. www.sciformix.com/smartsourcingstrategy.

Europe
New EU Devices and Diagnostics Legislation Could Shake Up Drug Industry
The shockwaves from the current European Union debates in Brussels on medical devices are likely to echo through the medicines business over the next few years, writes Reflector
...Read more

Pharmaceutical Executive editorial staff proudly introduces PharmExec TV, their latest high quality pertinent content in a brand new industry-breaking format.Tune In Now.

Clinical Trials
Europe: Still an Attractive Place for Clinical Trials?
At the end of this month, the European Medicines Agency will close the consultation on its draft policy on Publication and access to clinical-trial data. The aim of the policy is laudable: to open up as much information as possible into the public domain with the aim of stimulating new avenues of research. So far so good, it might seem. But what impact will the policy have on Europe being seen as an attractive place to conduct clinical trials?
...Read more

Improving Clinical Trial Management with cloud-based eTMF
LIVE WEBINAR: Tuesday 8th October, 2013 10:00 am GMT
Register Free at: www.pharmexec.com/etmf

Clinical Trials
Enhancing Racial Diversity in Clinical Trials
A new FDA report analyzing clinical trial subject demographic subgroups found that racial underrepresentation is prominent: trial participants are predominantly white and minorities, such as African Americans and Asians, are excluded. But diversity in clinical trials is important, writes Moe Alsumidaie
...Read more

New eBook
The Best of the Successful Product Manager's Handbook Volume IV
In the fourth volume of this four-volume set from the pages of Pharmaceutical Executive, you'll arm yourself with information and expert accounts to fortify your marketing plans against both the unexpected and the inevitable
...Read more

//Forest Laboratories (New York, NY) named Brenton Saunders, former head of Bausch + Lomb, as CEO and President, effective October 1. He succeeds Howard Solomon, who has served as Forest CEO since 1977.//Cardioxyl Pharmaceuticals (Chapel Hill, NC) appointed Dr Shi Yin Foo, formerly of Novartis, as Chief Medical Officer.//ERT (Philadelphia, PA) appointed Steven Herne as Executive Vice President and Chief Commercial Officer.//Amarantus Bioscience Holdings, Inc. (Sunnyvale, CA) appointed Mr F. Randall Grimes, MBA, as Director of Sponsored Research.//

October 2–4: How To Increase Patient Compliance, Improve Health Outcomes, & Lower Costs Through The Latest Digital Strategies
New York, NY.


October 14­–16: Healthcare Informatics session, Inaugural Strategic Business Exchange
San Antonio, TX.


November 13–15: 2013 HBA Leadership Conference
Boston, MA.


 
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