Life Science Compliance Update

February 09, 2016

Biosimilars Clinical Studies and Analytical Similarity Summit – Update on Biosimilars

This year, Pharma IQ, a division of the International Quality and Productivity Center, will be hosting the Biosimilars Clinical Studies and Analytical Similarity Summit, March 21 through the 23, in Boston, Massachusetts. Attendees to the Summit will receive key insights from industry thought leaders into some of the biggest challenges in the analytical and clinical phases of biosimilar drug development.

This Summit boasts a full agenda spanning all three days, starting with Pre-Conference events on March 21 at 9:00 am. The Pre-Conference workshop day consists of three workshops with a wide range of topics: Compare, Contrast and Comply with US and EU Regulations that Govern Biosimilar Product Development; Establishing Structural Comparability with Effective Preclinical Characterization Methods; and Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations.

Day One of the Summit gets off to a roaring start at 9:00 am with a keynote address given by Professor Andrea Laslop, the Head of Scientific Office at the Austrian Agency for Health & Food Safety, on the future of biosimilar approval in Europe. They keynote is followed by three discussions: one on the unique bioanalytical testing and clinical testing strategies for proving safety and efficacy; one on the legal and regulatory implications of "similarity" and "interchangeability"; and a third one on biosimilars regulations in the US market and where we are headed from here, presented by our very own Thomas Sullivan. The afternoon closes out with discussions on how to leverage the FDA's "Totality of Evidence" methodology for using foreign reference products, and how to reduce or eliminate nonclinical toxicity studies from biosimilar development programs.

Day Two of the Summit again begins with a keynote address, this time a regulatory update on Health Canada's new guidance for subsequent entry biologics, presented by Agnes V. Klein, M.D., the Director CERB, Biologics and Genetic Therapies Directorate, at Health Canada. Dr. Klein and Professor Laslop come together mid-day on Day Two to host a regulatory question and answer session, focused on similarities and differences in the market authorization of biosimilars, including regulatory, policy, and guidance background. Day Two ends with a presentation by Michael Retsky, a research associate with the Department of Environmental Health at the Harvard T.H.Chan School of Public Health, on the difficulty of using biosimilars in oncology and what can be done about it.

If you are interested in attending the Biosimilars Clinical Studies and Analytical Similarity Summit, you can register here. Those who register by February 19, 2016, could receive up to $400 off registration costs.

January 19, 2016

Webinar: Managing the Risk of Open Payments – Validate Spend Report Before CMS Submission

With the next filing period for spend data under the Sunshine Act coming up quickly, Ned Mumtaz and Brian Dahl are hosting a webinar on how to help you manage the risk of open payments and open payments reporting. The webinar will take place on Thursday, January 21, 2016, at 2:00 pm EST. The webinar will explain how you can work to protect yourself from risks of audits or fines, even before you submit your final report to the Centers for Medicare and Medicaid Services (CMS).

Mumtaz and Dahl will discuss a range of important topics, including some of the potential implications of public availability of this data and how governmental authorities may use the Sunshine Act data to generate enforcement actions.

If you attend the webinar, you will learn how to run an independent audit on your spend before building state and federal reports, spot an outlier before submitting your final report, and improve your compliance program using data analytics.

Brian Dahl is the principal of Dahl Compliance Consulting, LLC, and is the architect of the Corporate Compliance Programs at both Teva Pharmaceuticals and Takeda Pharmaceuticals. Ned Mumtaz is leading Streebo's transparency directive program in the United States and European Union; he has over twenty years of experience in the pharmaceutical industry and has led several Sunshine implementation programs in the United States.

The webinar is moderated by Thomas Sullivan, the Chief Editor of Policy and Medicine. Policy and Medicine has been the number one information source for the Physician Payment Sunshine Act for the past five years, according to Google.

If you are interesting in attending, you can register here.

January 13, 2016

CBI’s Pharmaceutical Compliance Congress 2016

This year, CBI is hosting the Thirteenth Annual Pharmaceutical Compliance Congress (PCC) January 26 – 27, 2016, at the Ritz Carlton in Washington, D.C.

This two-day event is packed with programming, including discussion of issues such as mergers and acquisitions, global transparency, off-label promotion, risk monitoring, cross-border compliance, and enforcement priorities.

Day One of the event starts with an opening address from Ashley Watson, Chief Ethics and Compliance officer at Merck & Co, Inc., who will be speaking about how to unite compliance and the business, to raise the bar and reinforce global collaboration. Following that is a showcase, where attendees will hear from leading Chief Compliance Officers on a variety of the most pressing issues impacting today's business world. CCOs who will be on that showcase panel include: Trudy Tan, AstraZeneca; Jill Fallows-Macaluso, Novo Nordisk Inc.; and John Crisan, Johnson & Johnson. Later that morning, attendees will also hear from a selection of USAO on healthcare fraud enforcement trends and future compliance issues, and former prosecutors of high-profile healthcare fraud cases.

A Chief Compliance Officer Summit will take place the afternoon of January 26, where Chief Compliance Officers will be permitted to discuss common questions, challenges, and issues that are facing CCOs today. For those attendees who are not CCOs, many opportunities await them, including a choice of six varied workshops, covering a wide variety of material, including government pricing updates, pre-M&A due diligence, and the unique risks associated with specialty drugs. Following the workshops, attendees will have their choice of four different tracks of speakers, including tracks focused on product promotional compliance and compliance considerations for clinical research and R&D. At the close of day one, a wine and cheese reception is held for networking purposes.

Day Two opens with an update from the FBI, presented by Jeffrey S. Salley, Special Agent in Charge, followed by an address by Robin Usi, Director of the Division of Data and Informatics at CMS. Day Two continues with an option of five different tracks, ranging in topics from global and international compliance strategies to off-label risks and controls. Day Two ends with four working group discussion options, including one discussion on the 21st Century Cures Act and its impact on compliance, where attendees will engage in small group conversation with peers, sharing first hand experience and asking constructive questions to spark dialogue.

The PCC sees over 400 attendees annually in a variety of backgrounds, with 74% of attendees being from the bio/pharma/device community.

Additionally, this year, CBI is hosting a "PCC Prelude" the afternoon of January 25, 2016. There are two events that make up the PCC Prelude, both from 3:00pm – 5:00pm and invitation-only, the Emerging Leaders' Summit and the Advanced Think Tank Summit for Small Mid-Sized Life Sciences Companies.

If you are interested in attending the Thirteenth Annual Pharmaceutical Compliance Congress, you can register here. As an added bonus, Policy & Medicine readers are offered a $400* registration discount by entering the code PCCPM4 with their registration.

* This discount applies to standard rate and may not be combined with other offers or applied to an existing registration.


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