LIFE SCIENCE COMPLIANCE
Content update: Volume 2, No. 1, March 2013
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.
New Editorial board members:
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.
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.
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. ....
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.
Interactions with healthcare professionals
Fee for service arrangements, including clinical trials
Sponsorship to attend meetings and conferences
Meetings and hospitality
Gifts and marketing materials
Independence of prescriber decisions
Interactions with other government officials and decision-makers (e.g. health ministers, formulary decision-makers, payers)
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.
Managers in the key functions of Research & Development, Manufacturing, Sales & Marketing and Corporate divisions, e.g. Clinical Trials Managers, Sales Managers, Distribution Managers, etc.),
Corporate social responsibility managers,