Life Science Compliance Update

May

2017

Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support

Written by , Posted in Global issues

Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA

Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing.


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April

2017

Healthcare Reform – Chinese Style

Written by , Posted in Global issues

Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris

The PRC continues to focus on three principle life science industry concerns: (1) drug quality, development, and approval, (2) healthcare affordability; and (3) preventing bribery and corruption in the healthcare industry. The recently published “Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage” (“The Opinions”) continue and expand on those efforts.


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October

2016

EFPIA HCP Financial Disclosure Is Not Risk Free

Written by , Posted in Global issues

Ulf H. Grundmann, Partner, King & Spalding LLP, Frankfurt a.M. (Germany) and Elisabeth Kohoutek, Associate, King & Spalding LLP, Frankfurt a.M. (Germany)

A large number of pharmaceutical companies across Europe had until June 30, 2016 to disclose their financial interactions with health care professionals (HCPs) in order to comply with the guiding principles of the EFPIA disclosure code. There are several legal regulations complicating compliance with EFPIA disclosure requirements. This article explores those complications.


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May

2016

Growing Like Weeds – MedTech Europe Adopts New Code of Ethical Business Practice

Written by , Posted in Global issues

Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update and Veronique Monjardet, Ph.D., Country Manager, France, Polaris
MedTech Europe adopted a new Code of Ethical Business Practice late last year. This article explores the purpose of the new Code, standards found in the new code, as well as some material differences between this new Code and other Codes currently in existence.


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March

2016

A Different Mindset – Challenges of Working in China

Written by , Posted in Global issues

By: Kaitlin P. Fallon, Esq., Staff Writer for Life Science Compliance Update

Life Science companies are increasingly doing business in China. However, recent events reveal the complexities and challenges of operating on the mainland. This article explores some of those challenges and how to navigate those complexities.


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March

2016

One Code to Bind Them All – Doubtful

Written by , Posted in Global issues

By: Kaitlin P. Fallon, Esq., Staff Writer for Life Science Compliance Update

Life Science Compliance officers have many responsibilities within their organizations, revolving around ensuring full compliance with all relevant laws. Complicating matters, there are many different associations a life sciences company can belong to, each with its own Code of Conduct. What follows is a brief overview of the ethics codes of some of the more prominent industry associations.


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March

2016

Yet Another Code for Interacting with HCPs – The EGA Adopts a New Code of Conduct

Written by , Posted in Global issues

By: Dr. Seth Whitelaw, Editor and Mohamed Gorrafa, JD, Staff Writer for the Life Science Compliance Update

Despite the number of pre-existing industry codes governing interactions with Healthcare Professionals, the European Generic Medicines Association (EGA) recently promulgated its version. Although the new Code of Conduct builds off of its predecessors, it attempts to address some of the remaining problematic areas. This article explores the new Code and some its novel tenets.

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February

2016

Yet Another Code for Interacting with HCPs – The EGA Adopts a New Code of Conduct

Written by , Posted in Compliance operations, Global issues

By: Dr. Seth Whitelaw, Editor and Mohamed Gorrafa, JD, Staff Writer for the Life Science Compliance Update

Despite the number of pre-existing industry codes governing interactions with Healthcare Professionals, the European Generic Medicines Association (EGA) recently promulgated its version. Although the new Code of Conduct builds off of its predecessors, it attempts to address some of the remaining problematic areas. This article explores the new Code and some its novel tenets.


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