Thank you for your interest in membership in the REMS Industry Consortium (“RIC”). We are excited to receive your application to join RIC and participate in our initiatives that seek to foster collaboration and innovation to advance patient safety, appropriate access, and best practices in REMS-related drug and biologic risk management.
Our initial membership offer is for organizations that are commercializing (or are developing for commercialization) FDA-approved pharmaceutical or biologic products that are subject to REMS. If you are a vendor or supplier to the REMS Industry and you're interested in joining the RIC as an Industry Partner, please contact Christina DeRose directly at firstname.lastname@example.org.
Annual Membership Dues – (Check one) - Organizations (that meet the membership criteria) are invited to participate at either the Group or Enterprise level:
*NOTE: These “Group” & “Enterprise” Dues options are available for a limited time only. Annual dues are subject to change.
Membership in RIC is currently reserved for organizations that meet the following membership criteria: (a) any entity that is a drug or biologic company sponsor (i.e. a New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA) holder, or similarly situated party, such as a licensee of such an entity) which (i) engages in commercializing (or developing for commercialization) FDA-approved pharmaceutical or biopharmaceutical products which are (or may be) subject to REMS, and (ii) supports furthering the goals of RIC, including undertaking activities to further those goals.
RIC goals include: (a) communicating, promoting and supporting best practices relating to United States Food and Drug Administration Risk Evaluation and Mitigation Strategies; (b) promoting the formulation and communication of clearly defined regulatory requirements relating to REMS programs; (c) enhancing understanding of, and promoting the simplification and streamlining of processes relating to REMS programs for patients (and their caregivers), prescribers, pharmacies, manufacturers, distributors, wholesalers, and drug/biologic companies; (d) promoting and advancing the science of drug safety and risk mitigation (as it relates to REMS) for patients; (e) supporting standardization of FDA interactions to improve predictability and expedite implementation of REMS regulatory requirements; (f) identifying vendor and technology issues relating to the operation of REMS programs and proposing solutions; and (g) developing common industry resources, including but not limited to training materials and educational programs for REMS stakeholders.
The purposes and business of RIC will be focused on general matters related to REMS, and not on any specific product, REMS program or stakeholder. No act or activity of RIC will be designed for the purpose of favoring or disadvantaging any drug (whether brand, generic, biologic or biosimilar) over another, or any REMS program (whether single-product or shared-system) over another. RIC will endeavor in good faith to pursue equitable representation of the interests of brand, generic, biologic and biosimilar market stakeholders.
Applications are subject to review and approval by RIC, including confirmation that applicants meet necessary criteria for membership, and membership classifications (as applicable). RIC reserves the right to reject an application for membership or opt to not renew a membership. If membership is approved, Voting Member organizations are permitted to designate up to three representatives for each Working Group or Task Force. This benefit is subject to modification by the Board at its discretion.
REMS Industry Consortium, 1120 Route 73, Suite 200, Mt. Laurel, NJ 08054. Questions may be directed to: email@example.com or 856-380-6894