Best Practices Working Group
Develop proposed standard timelines, definitions and submission content & consistent tactics for products with similar risk profiles etc.; leverage industry experience and identify tactics to streamline REMS program elements and enhance efficiencies for stakeholders (e.g. FDA, physicians, pharmacists, distributors, patients, caregivers, vendors). Create REMS best practices document package to include both FDA-focused (e.g. Shared System or Single Product REMS documents) and industry working group-focused materials (e.g. Confidentiality Agreement (CDA), REMS Participant Agreement (RPA)); coordinate with the FDA Interactions Working Groups as warranted.
Liza Rodriguez, Co-Leader
Stephanie Streib, Co-Leader
Communications and Marketing Working Group
The Communication and Marketing Working Group distributes RIC’s thought leadership, promotes our work product and amplifies the RIC’s voice in discussion of REMS industry priorities. This team conducts qualitative review and provides quality control and feedback for materials generated by all Working Groups. Responsibilities include developing the RIC Communications Plan, overseeing RIC branding and messaging, and developing target profiles of members and potential members. In addition, the Working Group identifies topics for white papers and supports publication.
The Annual Conference Planning Task Force (led by Dr. May Chan-Liston and Sherice Mills) is a subgroup of the Communication and Marketing Working Group that establishes, in alignment with the RIC Communications Plan, the vision, objectives and programming for the annual gathering of RIC members and industry stakeholders (slated for Spring 2023).
Kal Elhoregy, Co-Leader
Rebecca Zonin, Co-Leader
Education/Certification Working Group
The Education/Certification Working Group is developing educational resources and RIC credentialing programs for various stakeholders, including the development of core curriculum and ancillary training modules.
Sheline Way, Co-Leader
Andrew Yazwa, Co-Leader
FDA Interactions Working Group
The FDA Interactions Working Group seeks to engage with the FDA by responding to FDA outreach on REMS-related initiative and preparing recommendations for the FDA on ideas generated by working groups and task forces.
Brianna Gallagher, Co-Leader
Sherice Mills, Co-Leader
Vendor, Innovation & Technology Working Group
The Vendor, Innovation & Technology Working Group is exploring ways to increase vendor capabilities and identifying tactics to spur innovation and technology improvements.
Kyle Irwin, Co-Leader
Rahul Natarajan, Co-Leader