LIFE SCIENCE COMPLIANCE

 

 

Content update: Volume 2, No. 1, March 2013

 

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Our first article in this issue comes from Elisabethann Wright and Alexander Roussanov of Hogan Lovells and highlights the implications of EU data privacy rules for global product helplines.

 

James Paterson, founder of Risk & Assurance Insights Ltd, and a former Head of Internal Audit at AstraZeneca, takes us through how to run an effective internal audit department with special focus on the relationships and interactions between Internal Audit and Compliance.

 

We move to the USA for our next article by Karen A. Popp and David J. Ludlow who are both partners in Sidley Austin LLP’s White Collar, Government Investigations, and FCPA practices team. The US Department of Justice and Securities Exchange Commission recently issued guidance on the Foreign Corrupt Practices Act (FCPA). Whilst the FCPA is a piece of US legislation, it has global impact (the clue is in the word “foreign”) and there will be few organisations operating within the Life Science industry that will not need to take note of this guidance.

 

Next, we have an Opinion article from Nick Broughton of Pharmaceuticalethics.com, who asks “Can Pharma Be Loved?”. This article is the first in a series of articles intended to challenge our thinking about our industry.

 

Each issue from now on will feature a Case Study that will set out a situation for discussion online among our readers and contributors. Edited highlights from the online discussion will be published in the following issue together with the next Case Study for discussion. This should help to bring your challenges to life by gathering many different views on a hot topic. Do join us for the online discussion; the LinkedIn group name is “Life Science Compliance Discussions”.

 

We complete this issue with a review of the 13th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum held in Washington from 5th to 7th November 2012.

 

 

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New Editorial board members:

 

Reinhard-Angelmar Reinhard Angelmar,
Emeritus Professor of Marketing, and The Salmon and Rameau Fellow of Healthcare Management, Emeritus, at INSEAD, Fontainebleau, France.

Professor Angelmar has been directing INSEAD’s Healthcare Compliance Leadership Programmes since their start in 2007. Initially designed only for Johnson & Johnson, the programme was opened up to other companies in 2009 and has since attracted compliance professionals from around the world and from many pharmaceutical and device companies. He also teaches a course on “Pharmaceutical Marketing Strategy” in the INSEAD MBA program and has designed and directed tailormade INSEAD programs for organizations including Amgen, Janssen Pharmaceuticals, Eli Lilly, LEEM (Les Entreprises du Médicament), Pfizer, Sanofi Pasteur, Takeda, and the World Medical Association. Professor Angelmar has also been involved as executive teacher or consultant with Abbott, ALK-Abello, Almirall, AstraZeneca, Bristol-Myers Squibb, Grünenthal, Ipsen, Novartis, Novo Nordisk, and Roche. He has carried out assignments as an expert in litigations between pharmaceutical companies. Professor Angelmar holds a Diplomkaufmann degree from the Vienna University of Economics and Business Administration (Austria), and MBA and PhD degrees from the Kellogg School of Management, Northwestern University, Evanston IL (USA).

 

 

 

chris-zalesky

Chris Zalesky,
Vice President, Global Policy & Guidance, Johnson & Johnson Health Care Compliance & Privacy.

 

Chris Zalesky has more than 20 years experience in regulatory affairs, quality assurance and research and development functions within the medical device and pharmaceutical industries. He has published numerous articles on regulatory, FDA and health care policy matters and has contributed to several successful regulatory policy and legislative initiatives. Mr. Zalesky provides guidance on a range of compliance matters and is admitted to practice in Pennsylvania.

 

 

 

Dear Reader,

 

Welcome to the fourth issue of Life Science Compliance. As a brief reminder, the aim of the Journal is to provide information for those working in compliance and related fields in life science companies, law firms and consultancies.
From this issue onwards, we welcome both Reinhard Angelmar and Chris Zalesky as new members of our Editorial Board. Reinhard is Emeritus Professor of Marketing and the Salmon and Rameau Fellow of Healthcare Management, Emeritus, INSEAD, Fontainebleau, France. Chris is VP, Global Policy & Guidance, Johnson & Johnson Health Care Compliance & Privacy.

Our first article in this issue comes from Anthony Murphy, who has many years’ experience of working internationally, both in private companies and for the UK government, although he has never worked in our industry. ....

 

 

 

 

 
Aims
 
The aim of the Journal is to provide factual information and case studies regarding all aspects of Compliance for companies operating in the Life Sciences sector across Research & Development, Manufacturing, Sales & Marketing and Corporate activities to inform compliant decision-making across the Life Sciences sector. The initial focus for the first few issues of the journal will be Sales & Marketing compliance, as this is currently the highest risk area for companies.

 

Scope

The scope will include:

 

Regulations, laws and industry body codes of practice governing all aspects of the Life Sciences sector, including anticipated changes,

 

Case studies of how companies have complied with the legal, regulatory and code requirements, including practical suggestions for improvements and potential technology solutions,

 

Reporting on sanctions imposed on companies for various non-compliant activities, including implications for other companies and what could have been done differently,

 

Independent reviews of services and technologies available to help keep companies compliant.

 

Main topics

Interactions with healthcare professionals
Fee for service arrangements, including clinical trials
Sponsorship to attend meetings and conferences
Meetings and hospitality
Gifts and marketing materials
Market research
Independence of prescriber decisions

 

Interactions with other government officials and decision-makers (e.g. health ministers, formulary decision-makers, payers)

 

GxPs
Good Laboratory Practices
Good Clinical Practices
Good Manufacturing Practices
Good Distribution Practices

 

Grants and donations

 

Data protection and privacy, particularly around implementation of company hotlines

 

Use of electronic media in the marketing mix, e.g. Facebook, twitter, micro-sites, etc.

 

Audience

Compliance officers,
Managers in the key functions of Research & Development, Manufacturing, Sales & Marketing and Corporate divisions, e.g. Clinical Trials Managers, Sales Managers, Distribution Managers, etc.),
Internal auditors,
Risk managers,
Ethics officers,
Corporate social responsibility managers,
Consultants,
Lawyers.