Life Science Compliance Update

October 29, 2015

The Fourth Annual Corporate Compliance & Transparency in the Pharmaceutical Industry Europe

The Fourth Annual Corporate Compliance & Transparency in the Pharmaceutical Industry, presented by Fleming Europe, will take place February 24 – 25, 2016 in Zurich, Switzerland.

The two-day event is packed with speakers who will aim to provide attendees with: an update on the implementation of the Disclosure Code and the first outcomes and how to evaluate your implementation process; tips on how to unravel compliance challenges relating to data privacy; an understanding of how to optimize interactions with health care providers and health care organizations through a fully compliant and transparent strategy to obtain consent; and information on compliance implications and concerns for merging corporate cultures.

On Wednesday, February 24, 2016, the day will begin with an update on implementation of the disclosure code from the European Federation of Pharmaceutical Industries and Associations. Richard Bergstrom of the EFPIA will discuss do's and don't when implementing EFPIA's codes, what will happen once the data is disclosed, and challenges relating to external communication and specific countries relating to disclosure. The morning continues with three separate discussions about transparency: a panel on transparency obligations; a panel on local perspectives – disclosure and transparency lessons learned; and keynote on data privacy and transparency requirements under the EU Data Protection Directive. Following lunch, the afternoon brings more panels and discussions, including a talk on how to determine fair market value, a keynote from Adrien Van Den Hoven of European Generic and Biosimilars Medicine Association, and a case study on communication and relationships with health care providers. Wednesday ends with a networking cocktail reception.

Thursday, February 25, 2016, begins with a panel on best practices: compliance program structure and effectiveness, with speakers from Sandoz, Acino Pharma AG, and Biogen. Following the panel, Nina Stoeckel from Merck KGaA will speak about how critical team structure is to success. Marit Pless will conclude the morning session by providing a roadmap for conducting internal investigations. The afternoon will be spent hearing from representatives from AstraZeneca and Johnson & Johnson on topics such as compliance and risk assessment and how to organize an approach for communicating, training, and monitoring third parties.

If you're interested in attending the Fourth Annual Corporate Compliance & Transparency in the Pharmaceutical Industry, you can register here.

October 02, 2015

CBI Sixth Annual West Coast Compliance Congress


CBI's Sixth Annual West Coast Compliance Congress will take place November 5-6, 2015 at the Hyatt Fisherman’s Wharf in San Francisco, California.

This year’s West Coast Compliance Congress is in a new format that allows attendees to customize their experience and learning opportunities, depending on their field and interests. This year’s Compliance Congress boasts over forty speakers representing small, mid-size, and large bio/pharma and device manufacturers.

On Thursday, November 5, 2015, the day begins with an opening address followed by a compliance officer panel and an enforcement panel. Doug Brown of the Centers for Medicare and Medicaid Services (CMS) will also give an address from his agency, likely covering Open Payments. Following the lunch break, there are several breakout sessions with different track options, including: compliance program structure and effectiveness; promotional compliance; and HCP contracting and communications. The day ends with a wine and cheese networking reception.

On Friday, November 6, 2015, the morning gets off to a start with a physician keynote by Dr. Maya A. Babu, who will discuss Open Payments reporting from a healthcare provider perspective. The day will then again split off into breakout sessions, including topics such as: auditing, monitoring, and investigations; global anti-bribery and international compliance; and global transparency reporting and tracking HCP payments.

If you’re interested in attending this year’s West Coast Compliance Congress, you can register here

October 01, 2015

The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress


The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress will take place October 21 – 23, 2015 at the Mandarin Oriental in Washington, D.C.

The conference is scheduled to take place over three days; however, the last day is a closed session for an industry-only compliance best practices think tank.

On Wednesday, October 21, there are four different pre-conference tracks in the morning before the conference officially begins at 1:00 pm. The pre-conference tracks cover a wide variety of topic areas, including: basic principles of regulatory concepts; innovations in risk assessment, auditing and monitoring; taking data to the next level in domestic and global transparency; and global compliance issues. Once the conference officially gets under way, the first keynote will be an update provided by Mary E. Riordan, Esq. of the Office of Inspector General of the Health and Human Services. Following Ms. Riordan’s update from the HHS OIG, the next keynote will be an update on the Food and Drug Administration’s Office of Prescription Drug Promotion, given by Thomas W. Abrams. The first day ends with an expert panel discussing an FCPA Anticorruption case, with input from the Department of Justice, the Securities and Exchange Commission, and compliance officers.

On Thursday, October 22, the morning starts out with updates from the DOJ and CMS. The middle of the day includes several different break-out sessions, covering multiple topics, such as: the recommended pre- and post-deal due diligence for companies acquired by other companies; how to evaluate compliance program effectiveness; how to coordinate risk management across the control functions; and innovation in training and communications. The day ends with a panel on millennials and the future of ethics and compliance programs and a keynote speech by Robert Barrington, PhD, on Transparency International’s New Pharma Industry Initiative.

As previously mentioned, the final day, Friday, October 23, is a closed session where attendance is limited to company compliance professionals and in-house counsel to facilitate a more focused exchange of views regarding issue priority and effective compliance practices.

If you’re interested in attending the Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress, you can register here


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