BALTIMORE , Sept . 26 , 201 3 – Compliance Implementation Services (CIS), a leading life sciences consulting firm, today announced that Judy Fox , Director, Transparency Compliance and Ryan Stewart , Manager, Audit & Risk Assurance , will speak at the 23rd Annual PDMA Alliance Sharing Conference , taking place in Baltimore, MD on September 29 - October 2 . Fox is a board member of the ho sting organization, The PDMA Alliance, and played an integral role in develo ping content for the conference, which focuses on life sciences compliance topics covering PDMA, f raud and abuse, aggregate spend and OIG g uidance , among others.
Alliance Board member Luanna Saulino will join Fox to kick - off the conference by conducting, “Aggregate Spend Compliance Training , " a course developed on the requirements, best practices and practical solutions for compliance to the Federal and State Compl iance and Reporting regulations. Th e course provides a real - time training initiative, including a post - conference refresher, practice and testing. In addition, Fox and PDMA Alliance President Mark Adams will moderate a special government agency town hall d iscussion . Agenc y speakers include :
- Doug Brown , Director, Health Informatics and Systems, Center for Program Integrity, CMS
- Anita Griner , PMP Deputy Director, Data Sharing & Partnership Group, Center for Program Integrity, CMS
- Kate Whelley McCabe , Assistant Attorney General, Public Protection Division, Vermont Office of Attorney General
- Thomas Novelli , Vice President of Government Affairs, MDMA
- Kendra Martello , Assistant General Counsel, PhRMA
“W e have been honored by the participation of elected and appointed government officials, FDA and CDER and other regulatory counsels, attorney generals and their assistants . These experts are always willing to share their knowledge and experiences with us , ” said Deb Segura, Executive Director of The PDMA All iance.
Stewart and David Hollasch, Auditing and Compliance Director at Warner Chilcott , will present the workshop , “Developing Separate but Aligned Monitoring and Auditing Strategies to Detect Areas of Potential Noncompliance.” Drawing upon their industry experience, Stewart and Hollasch will discuss a case study on the difference between monitoring and auditing, the im portance of an audit plan, and look at CIA trends in monitoring requirements.
“We are pleased to contribute t o t his year’s conferen ce and to support the goals of T he PDMA Alliance in its important work to provide a forum to share news and valuable insights on compliance issues . We are a good fit for this organization as our perspectives, products and services are designed to make the burden of meeting compliance requirements easier,” said Fox.
In connection with this event, CIS will feature special resources designed to help compliance professionals navigate government documents more efficiently. These resources include a CMS “Frequently Asked Questions” monitoring service and a searchable Sunshine Act Final Rule. CIS is also a participant in the PDMA Alliance’s vendor case study program and will provide this and other case studies on CIS’ service offerings and client projects.
CIS has pr ovided compliance and transparency reporting services to over 30 clients within the past five years through its CR Partner ® service offering. To request a copy of the conference resources or other CR Partner ® reference materials, contact CIS at info@cis - partners.com .
About Compliance Implementation Services (CIS)
Compliance Implementation Services (CIS) is a consulting firm focused on helping life sciences clients proactively manage complex compliance requirements. We offer a broad portfolio of services and solutions that expand deep into the clinical, manufacturing and commercial disciplines and that align with our clients’ strategic priorities and business operations. CIS continually provides leadersh ip, global regulatory knowledge, industry experience and a problem - solving culture that responds to today’s compliance and commercial challenges. For more information, visit www.cis - partners.com
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