The 17th Annual Pharma and Medical Device Compliance Congress was held at the Mandarin Hotel in Washington, D.C from the 19th to the 21st of October, 2016.
The conference provided an excellent opportunity for senior representatives from the compliance, legal, transparency, legal affairs, commercial operations/marketing, and regulatory affairs industries to network and discuss operational best practices.
Attendees of the conference benefited from a sea of knowledge with regards to the EFPIA disclosure code, transparency and compliance. The conference covered many different subject matters, including:
– Improving compliance monitoring via the use of data analytics
– Real-world perspective on foreign bribery
– R&D compliance
– Leveraging publically available Open Payments data
– Advanced compliance issues for medical devices
– Achieving better compliance culture in regional offices
– HCP interaction risk management
– Shared ownership of effective compliance across business functions
– Structuring and promoting efficient corporate compliance programs
Day One – October 19th, 2016
Day one was a pre-conference day in which attendees could choose from three different pre-conferences. Preconference-I was titled ‘Managed Markets 101: Overview of the US payment systems for pharmaceuticals’ and featured speakers from Huron Consulting Group, King & Spalding and Deloitte & Touche LLP, etc.
Pre-conference-II was titled ‘Being prepared for external investigations, subpoenas, and OIG monitor interactions’ and featured speakers from Alix Partners, Assurance Services, Temple Law Center for Compliance and Ethics and the US Department of Justice, etc.
The third pre-conference was titled ‘Advanced Global Compliance Issues’ and was presided over by speakers from EFPIA, Bristol-Myers Squibb, Polaris and Porzio Life Sciences, etc. In the third pre-conference, a session titled ‘European Transparency and Compliance Monitoring Evaluation’ was presided over by Evelyna Lemaire, Marie-Claire Pickaert and George Fife of Takeda Pharmaceuticals International GmBh, EFPIA and Bristol-Myers Squibb respectively, provided information about the EFPIA transparency directive and even performed a comparison between it and the US Sunshine Act together with a country by country breakdown of the data privacy law.
At the same time, there was an invitation-only special morning session for Chief Compliance Officers of various organizations including Sunovion Pharmaceuticals, Inc., US Department of Health and Human Services, Eli Lilly and Otsuka Pharmaceutical Development & Commercialization, Inc.
The opening plenary session of the conference began at 1 PM and the ‘Welcome and Introduction’ session was presided over by Matthew D’Ambrosio and Glenna Shen of Sunovion Pharmaceuticals Inc., and Amgen Inc. respectively.
Day 1 also featured a Chief Compliance Officer Roundtable and FCPA Enforcement Panel along with a keynote in which an annual OIG update was delivered by Mary E. Riordon, Mary E. Riordan, Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services.
There was also an annual AUSA roundtable together with a keynote on transparency international on day 1 of the conference.
Day Two – October 20th, 2016
Day two of the conference opened with a morning plenary session, followed by an annual FDA-OPDP update and a session titled, ‘Behind the Bribe: Multiple Real-World Perspectives on How Foreign Bribery Occurs, Is Investigated, and Could Be Prevented’.
This session was spoken to by representatives of Front-Line Anti-Bribery LLC, US Federal Bureau of Investigation and Pfizer Inc.
From 10:30 am onwards, the conference featured several mini summits that were distributed as Block A, B, and C. Mini summit I in Block A was titled ‘Compliance considerations for the managed markets business.
Mini summit II was titled ‘R&D compliance’ and was presided over by representatives of Johnson & Johnson, Eli Lilly, and Company and Arnold & Porter etc.
Mini Summit III was titled ‘New ethics-based approaches to policies’ and featured speakers from AstraZeneca, Whitelaw Compliance Group, LLC and Pharmaceutical & Life Sciences Advisory Services, PwC.
There were a few other mini-summits in Block A as well, all of which were focused on compliance, global transparency and leveraging analytics for monitoring.
In Block B, there were six mini summits, out of which the first was titled ‘Leveraging publically available data: Taking Open Payment Data a step further’. In this mini summit, speakers Ellen Carman and Lee Taurman of Grant Thornton LLP stressed on the need for pharma companies to leverage available data to enhance value within compliance.
There were five other mini summits within this block, a few of which were titled ‘What’s new for training programs’, ‘Compliance 2.0: Shared ownership of effective compliance across business functions etc.
Block C featured seven mini summits in which the first was titled ‘Managed markets risk assessment and monitoring’.
The second mini-summit was presided over by Sergio Alegre of Osmotica Pharmaceutical LLC, Michael B. Dusseau of Allergan plc, Margaret Feltz of Purdue Pharma L.P., Kelly N. Reeves of King & Spalding LLP and John Patrick Oroho of Porzio Life Sciences. The mini-summit was titled ‘Beyond Transparency: HCP Interaction Risk Management’. The speakers of this mini-summit explained the importance of risk management within HCP interactions and the different steps that pharma companies can take to reduce their respective risks in this regard.
A few other mini summits in this block were titled ‘Advanced compliance issues for medical devices: Working through distributors’ and ‘Evolution of risk assessment and management programs’ etc.
qordata’s Founder and CEO, Mohammad Ovais, also spoke at a mini-summit on the topic ‘Next Generation Compliance: Using Analytics to Reduce Compliance Risks’. In the session, he covered many different topics, including:
– General compliance auditing and monitoring
– Advanced monitoring using Open Payments data
– Future analytics
– Competitor benchmarking and analysis
– Identifying outliers based on benchmarks and business rules
At the end of day two, the closing plenary session was presided over by Jeffrey Kawalek, Associate Director, Compliance Risk, Novo Nordisk.
Day Three: October 21st, 2016
Day three had multiple sessions going on at the same time. To begin with, there was an industry-only session for pharmaceutical company ethics and compliance professionals and in-house counsel only.
This session was spoken to by representatives of Sunovion Pharmaceuticals Inc., Pfizer, Novo Nordisk and Amgen Inc.
There was another session held on day three at the same time in which the Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), John Murphy, provided updates from PhRMA to the audience.
After a break, three featured a facilitated small group best practice sharing on key topics after which the conference was adjourned.
All in all, the conference was a huge success, and qordata is glad to have been a part of it. Let’s not forget, our booth was one of the busiest, and our team outdid itself in responding to queries about how our Open Payments Analytics can help pharma companies manage the risk of Open Payments and report accurate data to CMS!
See other annual compliance events that qordata has attended over the years:
