Jigsaw Conferences compliant process and procedures ensuring the delivery to the Pharmaceutical and
Added: (Sat Feb 04 2012)
Pressbox (Press Release) -
JIGSAW CONFERENCES has a clear understanding of both the regulatory and practical requirements for HCP meetings. They have a comprehensive understanding of the audiences involved in meetings, the requirements of their clients and, most importantly, the regulatory environment in which they have to operate in the UK, US and Europe.
JIGSAW CONFERENCES understand the ethics in the spirit and practical application of meetings within the sector and the rules and regulatory requirements, Codes of Practice and protocol that have to be supported. JIGSAW CONFERENCES understand the confidential nature of the pharmaceutical sector and have adopted Standard Operating Procedures (SOPs) and processes to support and implement the regulations to ensure compliance.
JIGSAW CONFERENCES has proven experience in working with pharmaceutical clients’ SOPs and will work with the Company Compliance team to ensure ongoing adherence and seamless management of any changes.
All JIGSAW CONFERENCES staff, including freelance staff, receives compliance training including current Codes of Practice and anti corruption legislation both UK and US FCPA. Furthermore, our compliance measures and regular audits ensure that all partners and suppliers will be fully conversant with client-specific SOPs and our own internal standards for operational excellence.
JIGSAW CONFERENCES offers experience with client SOP adherence, phRMA, European Federation of Pharmaceutical Manufacturers Associations’ (EFPIA), pharmaceutical specific country code compliance, implementation methodology through the clear process, as well as strategic and delivery solutions for meetings technology, creative and live communications, purchasing strategy including payment card solutions for meetings management and advice and guidance on the recovery of VAT.
JIGSAW CONFERENCES has been very successful in establishing controls for compliance and audit. They understand that each company’s interpretation of the various codes and regulations is unique, covered in internal processes and procedures. They will follow the customer’s guidelines while managing the program and will often include a compliance manager on staff to certify that guidelines are enforced and adhered to from end-to-end, particularly with HCP meetings. The guidelines include interim meeting compliance checks throughout the process to prevent non-compliance issues and/or gaps in the process.
Their process for creating SOPs, training and ongoing management has also contributed to our success in managing pharmaceutical meetings.
To guarantee reassurance to our pharmaceutical clients that JIGSAW CONFERENCES is a robust agency and qualified to manage programs for this sector on a global basis, we have made considerable investment in the area of Compliance.
In Europe, JIGSAW CONFERENCES achieved affiliation to the ABPI Code of Practice in June 2009 - one of only five UK agencies to achieve General Affiliate status - and accreditation from the Select Agency Support Programme (SASP), a Code Compliance and accreditation service. To manage and oversee processes they have a Compliance Team, headed by the Compliance Officer.
Please clearly explain your understanding of The Sunshine Act and other similar legislation (in the U.S. and other countries).
While staying abreast of all aspects of the travel industry is imperative to remain a leading-edge service provider, it is also important that we understand the nuances of our customer’s industries. Our extensive global experience with pharmaceutical industry customers has enabled us to develop a valuable depth of expertise in managing the unique requirements of this complex industry.
The Physician Payment Sunshine Act became law in the United States in March 2010 and will have a considerable impact on the pharmaceutical industry FROM 2012/13. This legislation is designed to provide transparency to physician payment from pharmaceutical and medical device companies
The end goal of the Sunshine Act is provide full disclosure of physician payments in a searchable database making it easier to investigate and eventually prosecute healthcare fraud. Pharmaceutical companies are required to begin the aggregate spend for HCPs in 2012 and begin reporting on this data in 2013.
JIGSAW CONFERENCES continues to stay abreast of this legislation as it develops and can gather aggregate spends in preparation for these requirements. This piece of Congressional legislation has a direct effect on meeting spend per HCP and it is prudent that we stay on top of the legislation as it develops. Our approach is to be proactive, rather than reactive, with the training of our teams and creation of SOPs and detailed tracking of all payments to HCPs across all sectors. JIGSAW CONFERENCES are able to formulate a comprehensive report for companies on the payments made, for our pharmaceutical customers.
Although more prevalent for US companies the UK ABPI changes have instigated a similar requirement from 2012 with payments being made transparent and public for meetings, congress and the like.
How do you, or how are you planning to, assist your current clients in meeting the reporting 2012 tracking requirements of the Sunshine Act, as well as the overall requirements of US state reporting and federal compliance obligations for HCPs?
JIGSAW CONFERENCES assist our customers in gathering data inline with the Sunshine Act. Our proprietary reporting program provides our pharmaceutical customers with an accurate yet flexible platform in which to gather the level of detail required by this legislation and assist our customers in compliance. We can customize the reports to meet our customers individual needs as well as provide them with reporting broken down by commodity per HCP.
Reporting processes, which are normally tailored for a specific client, are vital not only in relation to the Sunshine Act but also to manage the new 2012 ABPI Code of Practice and UK Bribery Act requirements.
How does your company manage the different compliance requirements in different countries and the changing regulations in the pharmaceutical industry?
All JIGSAW CONFERENCES staff including freelance staff receives Compliance training. Furthermore, our compliance measures and regular internal and external audits ensure that all partners and suppliers remain fully conversant with client-specific SOPs and our own internal standards for operational excellence.
We ensure that the knowledge of the phRMA, ABPI, EFPIA and country Codes is maintained through having access to over 30 country Codes of Conduct.
JIGSAW CONFERENCES employees are fully conversant in pharmaceutical codes in the following countries: U.S. (PhRMA), UK (ABPI), Germany (Ehrenkodex), Belgium (Code of Deontology/ Pharma.be), The Netherlands (Dutch Code of Conduct), The Nordics (LMI/LF/LIF/PIF), Spain (Farmaindustria) and France (LEEM). We will develop policies and procedures to assure complete compliance with industry regulation.
Knowing that every pharmaceutical company has their own way of interpreting, following and enforcing regulations, JIGSAW CONFERENCES will work with the client company to understand your company's point-of-view and follow suit accordingly. We will conduct training on compliance requirements at time of hire and provide refresher training on the relevant Codes and company guidelines annually or when significant code changes arise.
We will train our employees to comply with your unique guidelines and practices, particularly for meetings with HCPs in attendance. While team members may not be responsible for initiating all actions surrounding compliance of a meeting, they go through in-depth awareness training.
Some examples of the topics are:
· FCPA
· Office of Inspector General (OIG) Overview
· PhRMA Code interactions with HCPs
· Continuing Medical Education and Promotional Meeting Overview
· Fair Market Value Overview
· Review Committee (RC) Overview
JIGSAW CONFERENCES takes compliance with all country Codes of Conduct and their constitutions extremely seriously and will always conduct a thorough review to ensure the demands of each are met. All challenges and concerns will be raised with Eisai to ensure transparency and understanding from both sides. We have many multi-lingual staff and can ensure that all governmental requirements are met in a timely manner as to not affect the delivery of meetings across all countries.
In JIGSAW CONFERENCES opinion, every individual, including front line positions, supporting a pharmaceutical account bears some measure of responsibility for compliance assurance. This would include purchasers, planners and registration managers who are in daily contact with suppliers, stakeholders and attendees.
While one individual is typically the primary point-of-contact for managing compliance issues and resolution, we train the entire team to support compliance initiatives and continually updated as pharmaceutical codes and company policy as they evolve. Where appropriate, JIGSAW CONFERENCES also takes an active role in the development of compliance guidelines, working with our customers to understand their interpretation of pharmaceutical code on a country-by-country basis, and establishing standard operating procedures accordingly.
In the U.S., compliance management duties often require a seasoned professional who is fully dedicated to handling all issues and communication surrounding compliance. However, depending on scope of work and skill set within the team, there may be viable alternatives for managing this important aspect. For example, the compliance point-of-contact for one of our pharmaceutical accounts was the project accountant. This person brought previous work experience that uniquely qualifies her to take on a dual role of meeting close out and reconciliation combined with compliance tracking and reporting.
In EMEA, having supported JIGSAW CONFERENCES in achieving affiliation to the ABPI in June 2009 (one of only five UK agencies to achieve General Affiliate status) and our SASP accreditation, JIGSAW Conferences’ Compliance Officer supports the entire compliance team structure in conducting our audit processes, both internal and external, to ensure compliance now and in the future.