Highlights of the 3rd Annual Global Compliance Congress for Life Sciences

cbi-conference-1The 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 cbi-conference-2President, 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, cbi-conference-3Medical & 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:cbi-conference-4

  • 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 cbi-conference-5was 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, cbi-conference-6Promote 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.

3rd Annual Global Compliance Congress for Life Sciences

Considered the most prestigious compliance congress for the life sciences industry, the 3rd Annual Global Compliance Congress for Life Sciences is back for 2016. Hosted by the CBI, the congress, which is to be held on the 16th & 17th of November, 2016 at the Hilton London Olympia, aims to provide the perfect opportunity for representatives of life sciences companies to network, share ideas and learn from one another. The topics to be covered at the conference include third-party due diligence, FMV, transparency and many other issues that the industry continues to face.

Featured Content for 2016

The conference features an impressive list of speakers from Porzio Life Sciences, LLC, Biogen, MediSpend, AstraZeneca, U.S. Department of Justice, Roche Pharmaceuticals, Allergan and Johnson & Johnson etc. Attendees of the conference will also be able to acquire insight to the following featured content for 2016:

– German Anti-Corruption Law Update

– EFPIA Address and Industry Panel on First EFPIA Public Disclosure

– Social Media Best Practices to Comply with Global Compliance Regulations

– Meaningful Standard Operation Procedures to Mitigate Risk

– FCPA Pilot Program and Key Updates from the DOJ

Kristin Buske, Principal Consultant, EFPIA of qordata will also be speaking at the conference on the topic ‘Solutions and Bright Ideas for Analysing Compliance Data to Ensure Global Compliance’. Our team looks forward to meeting you at the conference, and to help you learn how our pharmaceutical software and consulting solutions can help biotech, pharma and device manufacturing companies get the most out of their data by identifying payment trends, testing the correctness of their disclosure data and draw conclusions from it.

Upcoming Webinar on Data Driven Enforcement – Risks of Open Payments and Medicare Part D Data

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Earlier this year, prosecutors used both publicly available Open Payments and Medicare Part D data to allege and sue Insys Therapeutics Inc., in the state of Arizona. The manufacturer was accused of providing illegal kickbacks to physicians to get them to prescribe Insys’ drug Subsys for off-label uses. Eventually, the class action law suit was settled for $6.2 million by the manufacturer. For the record, this is the first time that a drug company has been accused of kickbacks through its publicly available spend and prescription data.

Join qordata as our Founder & CEO, Mohammad Ovais, partners with Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, to present a webinar on November 14th, 2016 at 11 am CST on the topic ‘Data Driven Enforcement – Risks of Open Payments and Medicare Part D Data. In the webinar, the speakers will provide a review of the cases against Insys Therapeutics and present insight to the data used as part of the allegations. Further, the speakers will also discuss how compliance teams can proactively analyze publicly available data to avoid risks of kickback violations.

If you are interested in learning about spend data validation, spotting outliers and analyzing spend and prescription data to avoid kickback allegations, then make sure that you sign up for this webinar HERE. Chief Compliance Officers, Directors of Compliance, Managers of Compliance, VP of Transpareny and any other interested parties are encouraged to attend the webinar.

Date & Time:

November 14th, 2016 at 11 am CST


Duration:

1 hour


Agenda:

– Implications of public availability of Open Payments and Medicare Part D data

– Evaluation of spend before CMS submission

– Highlighting high risk physicians using Medicare Part D and Open Payments data


Speakers:

[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column width=”5/12″][vc_single_image image=”6753″ img_size=”150X150″ style=”vc_box_border”][vc_column_text]Brian A Dahl
Principal, Dahl Compliance Consulting LLC
[/vc_column_text][/vc_column][vc_column width=”5/12″][vc_single_image image=”6836″ img_size=”150X150″ style=”vc_box_border”][vc_column_text]Mohammad Ovais
CEO, qordata

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Who Should Attend?

[/vc_column_text][vc_column_text]–CCO

–Director of Compliance (Transparency)

–Manager Compliance

– Compliance Analysts

– VP of Transparency

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Highlights of the 17th Annual Pharma and Medical Device Compliance Congress

The 17th Annual Pharma and Medical Device Compliance Congress was held at the Mandarin Hotel in Washington, D.C from the 19th to 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. Preconference-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 preconference was titled ‘Advanced Global Compliance Issues’ and was presided over by pharma-congress-1speakers from EFPIA, Bristol-Myers Squibb, Polaris and Porzio Life Sciences etc. In the third preconference, 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.

pharma-congress-2At 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 thepharma-congress-3 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 pharma-4Foreign 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 pharma-congress-5available 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 pharma-congress-6programs’ 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

In case you missed out on the session, feel free to check out our recorded video here.

At the end of day two, the closing plenary session was presided over by Jeffrey Kawalek, Associate pharma-congress-7Director, 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!

Highlights of the 4th Annual Pharma Compliance Europe Congress

The 4th Annual Pharma Compliance Europe Congress was held at Royal Garden Hotel, London, UK on the 5th and 6th 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 analyticsconference-1

– Overcoming the hurdles of data privacy laws

– Drafting the compliance programme of the future

– Achieving better compliance culture in regional offices

– Establishing a corporate compliant culture and implementing an ethical business conduct

– Understanding the changing market place and the compliance issues triggered by these changes

Day One – October 5th, 2016             

Day one of the conference started off at 8am with registrations and refreshments. Next were the Chairman’s opening remarks, which were followed by a session titled, ‘Adapting to a culture of transparency in line with changing societal expectations’. After that, a session titled ‘Crafting the compliance programme of the future’ that was presided over by Erik Eglite, Vice President, Corporate Counsel & Chief Compliance Officer-Legal, Lundbeck Pharmaceuticals USA. The session was followed by another titled, ‘Accountability and risk of the compliance programme’ by Peter Herrmann, Group Compliance Officer, Actelion.

In a panel session titled, ‘How to establish a corporate compliant culture and implement an ethical business conduct’, representatives from AstraZeneca UK, Actelion, Boehringer Ingelheim and Daiichi Sankyo Europe GmbH provided insight to the ways in which corporations can establish a compliant culture so as to ensure that they conduct their business in an ethical manner. There was also a session that was presided over by representatives of IMS Health.

conference-2Next, there were different sessions for attendees to choose from and were categorized under ‘Transparency and Reporting’ and ‘Compliant Marketing and Sales’. The sessions were knowledge packed and provided insight to the many aspects of European transparency trends, compliance policies, data privacy laws, interactions between HCP and sales teams and compliance with EFPIA’s transparency code. In her session titled “Transparency reporting and overcoming the hurdle of data privacy laws”, Anna Byrom, Associate Director Compliance – EUCA, Intercept, discussed in great details the many hurdles that data privacy laws pose to transparency conference-3reporting. In her session, she pointed out the importance of raising awareness amidst employees as well, the need to imply “simple messaging for cross border interactions and global functions”. In her words, “Some countries also require HCO consent. Some countries do not require any consent’ please confirm with your local compliance function/responsible person”.

The day came to an end with four different peer to peer roundtables on the topics “Managing consent to disclose and relationships with HCPs”, “Overcoming issues in running a compliance program”, “Dissemination and exchange of scientific information – the line between promotion and scientific exchange” and “Transparency”.

Day 2 – October 6th, 2016

Day 2 starter with the Chairman’s opening remarks, which was followed by an interesting case study on the topic, “Whistleblowing, a US perspective” that was presented by Blair Hamrick, who, conference-4along with Greg Thorpe blew the whistle on Glaxo SmithKline (where they served as sales representatives) by bringing their misdemeanors to light. 11 years have passed by since the time they made the great revelation in which they alleged that the manufacturer marketed its antidepressants Paxil and Wellbutrin for unapproved uses. In this session, Blair explained his story and provided information that proved helpful and knowledgeable for compliance leaders and the pharma industry in general. The case study was followed by a panel discussion on the topic “Whistleblowing and reporting in Europe” that was led by Sophie Peresson, Programme Director, Transparency UK.

One of the most informative workshops was presented by Dominique Laymand, Senior Vice President, Chief Ethics and Compliance Officer, Ipsen, under the title “Improving compliance monitoring through the use of data analytics”. There was a lot of take home value in this workshop considering that data analytics can go a long way in helping manufacturers ensure compliance.

Considering the fact that compliance is gaining more and more popularity within the industry, the role played by compliance officers is constantly evolving. This particular topic was discussed in great detail by Marc-Olivier Lamaro, Chief Compliance Officer, Sanofi Pasteur MSD in his session titled, “Role of the compliance officer, today and tomorrow”. When discussing digital compliance, he said, he brought up a basic, yet very important point and said, “If a promotional practice is unacceptable in person, it will also be unacceptable in a digital environment”. The day came to an end with a session by Marcel Maderitsch, Compliance Officer, Vifor Pharma, titled, “Delivering effective compliance training”.

Also, the workshop by qordata’s Practice Leader and Associate Partner, Ned Mumtaz, titled conference-5‘Making the EFPIA Physician Spend Numbers Talk’ was a huge success. The workshop covered various interesting topics including:

  • Summary of numbers from 2015 EFPIA disclosure
  • EU wide analytics
  • Country wide analytics
  • Company wide analytics
  • Business and compliance considerations

17th Annual Pharma and Medical Device Compliance Congress

The Seventeenth Annual Pharma and Medical Device Compliance Congress is being held from the 19th to 21st of October, 2016 at the Mandarin Hotel in Washington, D.C. The conference aims to bring together senior representatives from the compliance and legal industries to discuss best practices for compliance, and will feature an impressive list of speakers and attendees from Polaris, Porzio Life Sciences, Novo Nordisk Inc., Huron Life Sciences and the US Federal Bureau of Investigation.

Attendees of the conference will acquire the perfect opportunity to not just discuss, but promote the most effective corporate compliance programs and learn about latest developments within the field. Sponsored by the Pharmaceutical Compliance Foundation, the conference will allow attendees to go through presentations by leading company compliance professionals, prominent industry consultants, government regulators, legal counsel and in-house counsel – a must visit for those seeking three days of networking, continuing education and best practice sharing.

The conference will cover topics like:

– Improving compliance monitoring via the use of data analytics

– Achieving better compliance culture in regional offices

– Advanced compliance issues for medical devices

– HCP interaction risk management

– Shared ownership of effective compliance across business functions

– Structuring and promoting efficient corporate compliance programs

We at qordata look forward to seeing you at the conference. Through our pharmaceutical software and consulting solutions, pharma, biotech and device manufacturing companies can get the most out of their data to ensure pre-submission compliance to the requirements set by CMS.

Upcoming Webinar on Making the EFPIA Physician Spend Numbers Talk

[vc_row][vc_column][vc_column_text]Join qordata as our Practice Leader Life Science, Ned Mumtaz, presents an educational webinar on October 27th, 2016 at 11 am CST on the topic, “Making the EFPIA Physician Spend Numbers Talk: See What the Spend Data May be Telling Us”.

In this webinar, Ned will present a detailed review of the EFPIA transparency directive, physician spend numbers and delve into information pertaining to the countries that require/do not require consent along with future predictions. Additionally, he will dive into disclosed physician spend numbers from various member countries. The webinar will conclude on a note on how companies may start using consent management initiatives as a driver for improving the rate of consent.


Date & Time:

October 27th, 2016 at 11 am CST


Duration:

1 hour


Agenda:

– Review consent rate in various EFPIA member countries

– Deliberate upon physician spend details

– Deliver insights into disclosure reporting practices of pharma companies in EU

– Assess the initiatives companies can take to increase consent rates


Speakers:

[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column width=”5/12″][vc_single_image image=”8176″ img_size=”150X150″ style=”vc_box_border”][vc_column_text]Ned Mumtaz
Practice Leader Life Science at qordata
Ned Mumtaz has over 20 years of experience in the pharmaceutical industry. As the Practice Director for Pharmaceutical Services at qordata, he is leading the transparency directive[/vc_column_text][/vc_column][vc_column width=”5/12″][vc_single_image image=”8056″ img_size=”150X150″ style=”vc_box_border”][vc_column_text]Zafar Ahmed
Head of Marketing at qordata

Zafar Ahmed, Head of Marketing at qordata, will be moderating the webinar.[/vc_column_text][/vc_column][vc_column width=”1/6″][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

Who Should Attend?

[/vc_column_text][vc_column_text]–CCO

–Director of Compliance (Transparency)

–Manager Compliance

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Upcoming Webinar on Next Generation Compliance: Using Analytics to Reduce Compliance Risk

qordata has teamed up with Astellas Pharmaceuticals and Zimmer Biomet to present a webinar on September 20th, 2016 at 11am EST, providing information on how compliance officers can use data analytics to enhance existing compliance and monitoring programs to ensure compliance to Open Payments and state reporting requirements. Registrations for the webinar are currently open and you can sign up for it HERE.

Attendees will get to hear from Benjamin Yao, Director of Global Compliance at Astellas Pharmaceuticals, Kelly Tope, Director of Compliance at Zimmer Biomet and Mohammad Ovais, Founder & CEO at qordata. If you are interested in learning about transparency and compliance from these industry experts through the organized webinar, make sure that you register right away.

Date &  Time:

September 20th, 2016 at 11am EST

Duration:

1 hour

Agenda:

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  • General compliance auditing and monitoring
  • In office and speaker meal spend vs. policy (limits, attendees, caps, etc.)
  • Textbook and reprint distribution
  • “Advanced” monitoring using Open Payments data
    • HCP engagement across industry – KOL tiering
    • Product comparison (both general and research spend)
  • Future analytics
    • Samples provisions
    • Global spend: isolation of spend types by geographies
  • Find non-compliant payments
    • Exceeds caps
    • Improper recipients or arrangements
  • Identify outliers based on benchmarks and business rules
  • Competitor bench-marking and analysis
  • qordata’s Open Payments Analytics to analyze spending patterns and cover compliance risks

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Speakers:

 

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Benjamin Yao Director of Global Compliance at Astellas Pharmaceuticals
Benjamin Yao
Director of Global Compliance at Astellas Pharmaceuticals

Astellas

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Mohammad Ovais
Founder & CEO – qordata

qordata - Data is the new drug

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Kelly Tope
Director of Compliance at Zimmer Biomet

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Highlights of the 10th Annual Forum on Transparency & Aggregate Spend

 

CBI held the 10th Annual Forum on Transparency and Aggregate Spend at the Ritz-Carlton in Washington, D.C. from 15th – 17th August, 2016. The forum provided an excellent opportunity for pharmaceutical, biotech and medical device executives to connect and share information about best practices pertaining to Federal State and worldwide HCP reporting.

The conference delivered a sea of knowledge with regards to open payments, EFPIA disclosure code and compliance initiatives and risks. Transparency, in general, was the word of the day(s). The different subject matters that were covered in the conference included:

– Investigator payments and their fair market value

– Impact of EFPIA Disclosure Code and Open Payments reporting on U.S. & European meetings

– Clinical research and the transparency issues involved

– CMS update on Open Payments reporting

– The ways in which transparency programs can assist in mitigating compliance risks

– Legal and regulatory issues related to the utilization of transparency data

– Data analytics surrounding activities of key opinion leaders

– Recent enforcement initiatives and proposed changed in regulations

Day One – August 15th, 2016

Day one was a pre-conference day in which attendees were offered two pre-conference workshops. open payments reporting guidelinesThe first workshop was led by Nancy Lanis from Henry Schein, Inc., Michael Hunn from Draeger Medical Systems, Inc., and Gina Nese from MicroVention, Inc. and covered topics related to transparency reporting for loaner medical device, supplies, dental manufacturers and distributors.

EFPIA country consent ratesThe second workshop was led by Marlize Eckert from GCO (Global Conference Organisers) B.V., Deborah Munzer and Johan Holm from AstraZeneca, and Andrew Powrie-Smith from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and covered the impact of the EFPIA disclosure code and Open Payments on United States and European meetings and event management. Also covered in the workshop was a breakdown of physician consent by HCP across the EU.

Day Two – August 16th, 2016

Day two opened with a welcome and opening remarks from Richard Eschle, Pharm D., JD, Executive Director of Corporate Compliance and Ethics at Eisai, Inc. Following opening remarks, the keynote address was delivered by two distinguished members of CMS Division of Data and Informatics (DDI) including their director, Robin Usi. Their key message was that CMS is balancing the process of meeting complex federal healthcare transparency regulations and simplifying the data collection process for manufacturers, and that CMS and other federal regulators are regularly “mining the open payments data”. They continued to share 2015 data highlights too.

IMG_1536Next, two panelist from US Department of Justice and one panelist from Massachusetts office of the Attorney General helped attendees understand the trends in recent enforcement targets by their offices. The takeaways from the three panelists were: Ms. Laura M. Kidd Cordova – there is an increased use of data assets by their department and there is an inclination to pursue criminal and not just civil litigation, Mr. David M. Scheffler – the department is actively using data analytics as a tool and for every dollar ($1) the DOJ spends in investigating violations, they recover $6, and Mr. R. David Walk, Jr. – his department is actively swapping in data analytics resources for feet on the beet, and he noticed that 2015 open payments data is reflecting a sharp decrease in honoraria and a sharp increase in charity, and commented that such data results are often further explored.

Moving on, the President and CEO of MMIS, Michaeline Daboul presented case studies on how the publically available open payments data and analytics are currently being used by industry regulators and manufacturers. She further shared that qordata, Medispend and a few others are offering ready capabilities to help manufacturers mine the open payments data. The final morning session included distinguished industry compliance and transparency reporting directors from Ariad, Daiichi Sankyo, Sunovion and Shionogi pharmaceuticals and they discussed the usage of transparency data to assess compliance risk. The highlight of this panel discussion was their response to the question as to what keeps them up at night. Their summary responses were: not knowing what is in their data, concern about outliers in their data, concern about any data missing from their report, and concern about lack of readiness to answer the question, “you had the data, why you did not know what is in it?”

Source: Deloitte Development LLC
Source: Deloitte Development LLC

Regina Alvarado and Jamie M. Mastroianni from Deloitte & Touche LLP also presided over an interesting session that was titled, ‘Comprehend the Status of the Pending Nurse Practitioner Bill and Implementation Challenges’. As the title implies, the session covered the current status of the bill and the challenges associated with its implementation. Seth H. Lundy and Brian Bohnenkamp from King & Spalding LLP also led a panel titled ‘Will Federal and State Enforcers Work Together to Target Open Payments Data? An Update on Transparency Reporting at the State Level’. The afternoon then featured a panel on ‘Traversing Sunshine Reporting for Clinical Research and Ways to Improve It’ that was moderated by Seth Whitelaw, editor of Life Science Compliance Update and with panelists from the AMA, AstraZeneca, Johnson & Johnson, and HCA. Rounding out the afternoon was a panel on how to structure and initiate a global transparency compliance program. The panel was moderated by John Patrick Oroho from Porzio Life Sciences, LLC and featured Transparency Requirementspanelists from Bristol-Myers Squibb, AstraZeneca and Porzio Life Sciences, LLC.

Day Three – August 17th, 2016

Day three allowed attendees to decide how they wanted to spend their morning and what areas they wish to acquire more information about. There were ten concurrent sessions from which attendees could choose five to attend. The topics covered included how to improve systems for data remediation and validation, what an Open Payments audit would look like, how to manage differences between EFPIA and U.S. transparency regulations, and transparency disclosure guidelines around the world. Let’s not forget, qordata’s IMG_1537Practice Leader and Associate Partner, Ned Mumtaz, also led a workshop titled, ‘Rounding Out the Transparency Team – Adding Data Analytics’. In the workshop, he covered many different topics including:

– Adding analytics function to transparency reporting compliance team

– Enabling your compliance team to contribute more to building compliance and strategy

– Elevating the integration of IT, analytics and systems intelligence in the transparency reporting compliance program

The day ended with a presentation by Thomas Sullivan, an overview of the two full years of Open IMG_1534Payments data, media coverage of the data, and what that means for the future. 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!

10th Annual Forum on Transparency & Aggregate Spend

CBI is holding the 10th Annual Forum on Transparency and Aggregate Spend at the Ritz-Carlton in Washington, D.C. from 15th – 17th August, 2016.

The Annual Forum will provide pharmaceutical, biotech and medical device executives with an amazing opportunity to connect and share information about best practices with regards to Federal State and worldwide HCP reporting.

The conference will cover details of:

  • Transparency issues in clinical research
  • Utilization of transparency programs for the mitigation of compliance risks
  • CMS update on Open Payments reporting
  • Recent enforcement initiatives and proposed changes in regulations
  • Data analytics surrounding activities of key opinion leaders
  • Fair market value of investigator payments
  • Legal and regulatory issues pertaining to the utilization of transparency data

We at qordata look forward to seeing you at the conference. Through our pharmaceutical software and consulting solutions, pharma, biotech and device manufacturing companies can get the most out of their data to ensure pre-submission compliance to the requirements set by CMS.

Upcoming Webinar On Consent Management For Transparency Disclosure In The Pharmaceutical Industry

By June 30, 2016 pharmaceutical companies across Europe will disclose their financial interactions with health care professionals (HCPs) and health care organisations (HCOs), in line with the guiding principles of the European Federation of Pharmaceutical Industries and Associations (EFPIA) disclosure code. In most countries, members of the local affiliates of the EFPIA make up about 75% of the market for prescription medicine, and hence represent the majority of companies. With regard to given by the HCPs for individual disclosure. The pharmaceutical companies have had to put within the company and interactions with the customers. Companies have to ensure HCPs are informed and give consent freely, specifically and unambiguously for the disclosure. In addition, there are a growing number of European anti-corruption laws discussed and implemented, making the financial interaction between companies and HCPs/HCOs a very sensitive topic for pharmaceutical companies.

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