Membership Application

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 that is not you, don't worry! We highly value our partners and will have expanded membership opportunities in the near future.

Address:
I verify that my organization qualifies for RIC's current membership offering for organizations that are commercializing (or are developing for commercialization) FDA-approved pharmaceutical or biologic products that are subject to REMS.
Primary Representative:
(All voting, legal, and financial notices from RIC to the Applicant will be sent to this e-mail address unless the Applicant directs otherwise)
I would like to participate in the following Working Groups
See Descriptions Below

 

Working Group Descriptions

Best Practices Working Group

Purpose: 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 FDA Interactions & Standardization Working Groups as warranted.

Communications and Marketing Working Group

Purpose: 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 Fall 2022).

Education/Certification Working Group

Purpose: Develop educational resources; recruit subject matter experts; develop RIC credentialing programs for various stakeholders; identify topics for potential co-development with FDA; assess feasibility and desirability of partnership opportunities with other trade associations.

FDA Interactions Working Group

Purpose: Devise strategy for FDA communications and engagement; draft comments to FDA and respond to FDA outreach to industry on REMS-related initiatives; prepare recommendations for FDA and advocate for recommendations generated by working group and task forces (e.g. standard terms/definitions, templates).

Vendor, Innovation & Technology Working Group

Purpose:The Vendor, Innovation & Technology Working Group is exploring ways to increase vendor capabilities and identifying tactics to spur innovation and technology improvements.

Additional Representative(s):
I would like to participate in the following Working Groups
Accounts Payable Contact Name (if different from primary contact):
Billing Address:

Annual Membership Dues – Introductory Offer for 2022 Calendar Year * (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.

Payment Type:
Acknowledgement
(Print Applicant Name)

By Checking the "I Acknowledge" box on this Membership Application (“Application”) above, the Applicant acknowledges that that the following terms and conditions apply to this Application and RIC Membership.

  1. The Application is subject to acceptance by the RIC Board of Directors including verification of the Applicant’s eligibility for membership in a particular class or tier.
  2. Upon acceptance of this Application, the Applicant will become a RIC member only upon approval by the RIC Board of Directors and payment of initial and annual Membership Dues and Fees.
  3. The Applicant agrees to comply with all terms and conditions of RIC’s Certificate of Incorporation, RIC’s Bylaws, and such rules and policies as the RIC Board of Directors and/or any Task Force(s), Working Group(s) or other committees may from time to time adopt, including but not limited to requirements applicable to specific classes of Membership.

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:  info@remsconsortium.org or 856-380-6894