The 3rd Annual Global Compliance Congress for Life Sciences was held by the CBI at the Hilton London Olympia on the 16th & 17th of November, 2016. The conference provided an excellent platform for representatives of life sciences companies to network, share ideas and learn from one another. The ambiance at the conference was high-energy and offered lots of take-home value.
If anything, attendees of the conference acquired extensive knowledge pertaining to the EFPIA disclosure code, compliance and transparency. Speakers at the conference covered quite a few subject matters that included:
- Key updates on EU data protection regulation
- Improving HCP engagement
- Global Fair Market Values
- Global transparency initiatives
- Adhering to global compliance regulations
Day One – November 16th, 2016
Day one of the conference started with Welcome and Opening Remarks by Holly Kramen, Vice President, Global Compliance Officer, Circassia in which she provided extensive information as to how being part of the conference can help companies ease their compliance ‘pain’ and further provided details on law enforcement, FMV, bribery investigations, privacy, transparency reporting and so much more. Opening remarks were followed by a panel titled ‘Best Practices to Successfully Implement Global Compliance in the Life Sciences Industry and Beyond’. The panel was moderated by Michelle Axelrod, Vice President, Porzio Life Sciences, LLC and the panelists included representatives from AstraZeneca, Baxter Healthcare SA, Dentsply Sirona, Daiichi Sankyo Europe GmbH, Kautex Textron and Takeda Pharmaceuticals International AG.
The next session, ‘A Culture of Ethics – Shifting Focus from Enforcement to a Service-Based Approach’, was presented by Jesper Lund Bredesen, HQ-PARC Chair (MD), Divisional Director, Medical & Regulatory Science at H. Lundbeck A/S. Next, Michaeline Daboul, President and Chief Executive Officer, MediSpend, presided over a session titled ‘A Case Study Approach to Improving HCP Engagement’. This session was focused on helping the attendees learn about strategies pertaining to leveraging or replacing legacy systems for the enhancement of business processes, and to assist them in determining latest standards for the management of HCP engagement while ensuring adherence to laws, codes and company policies.
There was also an invitation-only CCO Summit in which the following topics were discussed:
- FCPA and Due Diligence
- Role of CCO in Risk Assessment and Monitoring
- Data Analytics and Patient Privacy
- Distributing Scientific Data as Non-Promotional Information
The summit was led by Marc-Olivier Lamaro, Chief Compliance Officer at Sanofi Pasteur MSD and featured two sessions titled ‘Bridging the Gap between Science and Promotion’ and ‘Key Updates on EU Data Protection Regulation, Patient Privacy and Consent’. The first was presented by Elisabeth Kohoutek, Associate at King & Spalding, whereas the second was presided over by Jim Koenig, Esq., CIPP, Leader, PH Privacy, Cyber and Data Implementation Solutions at Paul Hastings LLP and Holly Kramen, Vice President, Global Compliance Officer at Circassia. Next there was an FMV Summit by Geert van Gansewinkel, Partner and Managing Director Europe, Polaris, titled ‘FMV Framework and Calculation Best Practices in an Evolving Regulatory Environment’. There was an interactive session that was presided over by Stephanie Wingrove, Senior Director International Compliance & Ethics, Allergan and Andriy Kirmach, Senior Manager, International Compliance & Ethics, Allergan and was titled ‘Explore In-House Approaches to Calculate Global Fair Market Values’.
Mariana Kurlat of Pfizer, Alexey Kolotvin of Takeda Pharmaceuticals Company Ltd., and Timur Khasanov-Batirov of Dr. Reddy’s Laboratories presided over the last session of the day. The session was titled ‘Best Practices and Industry Trends when Conducting Business within Emerging Markets’ and provided a world of knowledge pertaining to principles of the compliance program implementation, disclosure codes in various EU countries and regulation on promotional activities of human medicinal procedures.
Day 2 – November 17th, 2016
Day two started with the Chairperson’s Welcome and Review of Day One, which was presented by Morne Voigt, Vice President, Head of Ethics and Compliance EMEA at Astellas Pharma Europe Ltd. Then there was an EFPIA keynote address that Marie-Claire Pickaert, Deputy Director General, EFPIA delivered under the title ‘Reflection on First EFPIA Public Disclosure and Outlook for the Future. The session delivered extensive knowledge on EFPIA’s vision and an overview of 2016 reporting of 2015 ToV. Next there was an EFPIA disclosure panel, which was followed by a networking and refreshment break.
Attendees were then given the choice to pick from two breakouts A and B. Breakout A was presided over by qordata’s Principal Consultant, EFPIA, Kristin Buske and was titled ‘Solutions and Bright Ideas for Analysing Compliance Data to Ensure Global Compliance’. The session was a hit and Kristin did wonders in terms of answering the questions raised by attendees. Breakout B was titled ‘Engage in Social Media While Adhering to Global Compliance Regulations’ and was delivered by Carla Arrieta Martinez, Corporate Communication, Roche Diabetes Care Spain. Breakout C featured an interactive discussion session titled ‘Engage Stakeholders to Improve Communication, Promote Transparency and Combat Bribery and Corruption’ and a panel titled ‘Create Meaningful Standard Operating Procedures to Mitigate Risk’.
After the breakouts, a U.S. Department of Justice Keynote Address titled ‘FCPA Pilot Program and Key Updates from the DoJ’ was delivered by Jacob Elberg & Daniel Kahn. The last session of the day was titled ‘Effective Third-Party Oversight Programmes to Combat Global Anti-Bribery and Anti-Corruption Risks — From Framework to Practice’ and was presented by Detlef Geiges, Compliance Assurance Lead EMEA, AstraZeneca Global Compliance and Chinwe Omoworare, Compliance Assurance Partner South Africa & Sub-Saharan Africa, AstraZeneca Global Compliance.
All in all, the conference was a major success and delivered a sea of knowledge pertaining to transparency, EFPIA disclosure, compliance and so much more.