When: Not specified - November 20, 2025
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 506-563-232# This committee is responsible for developing and executing the ARM strategy and recommendations related to coverage, payment and coding for regenerative medicine products. The committee is ARM’s liaison to CMS, as well as private insurers. *For questions or comments please... Details
When: October 2, 2018
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Call-In Information: Phone: 202-602-1295 Access Code: 506-563-232# The Regulatory Committee oversees development and implementation of the regulatory agenda for the Alliance. This includes prioritization of regulatory objectives with FDA and others as necessary. The Regulatory Committee is responsible for interaction with regulatory agencies at public hearings, meetings, roundtables, PDUFA negotiations, submission of comments to the regulatory docket, and other forums for public... Details
When: November 11, 2018
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 506-563-232# This committee is responsible for developing and executing the ARM strategy and recommendations related to coverage, payment and coding for regenerative medicine products. The committee is ARM’s liaison to CMS, as well as private insurers. *For questions or comments please... Details
When: December 5, 2018
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Desktop Dial-In Information: Phone:202-602-1295 Access Code: 421-140-803# For more information, please contact Rob Falb at [email protected] or Annie Hubert at [email protected].
When: December 6, 2018
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Desktop Dial-In Information: Phone:202-602-1295 Access Code: 421-140-803# For more information, please contact Annie Hubert, Director of European Public Policy at [email protected].
When: December 10, 2018
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Call-In Information: Phone: 202-602-1295 Access Code: 506-563-232# The Regulatory Committee oversees development and implementation of the regulatory agenda for the Alliance. This includes prioritization of regulatory objectives with FDA and others as necessary. The Regulatory Committee is responsible for interaction with regulatory agencies at public hearings, meetings, roundtables, PDUFA negotiations, submission of comments ... Details
When: December 17, 2018
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Call in: +1-202-602-1295, access code 506-563-232# (Onetouch Dialing: 2026021295,,,506563232#)
When: December 20, 2018
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 421-140-803# This committee addresses EU-specific issues and topics related to the regulatory framework of Advanced Therapy Medicinal Product (ATMP) development and manufacture. Its main objectives are two-fold: to contribute consistently and meaningfully to discussions and initiatives to improve the regulatory landscape in the EU, including where appropriate within individual member states and to highlight the... Details
When: December 20, 2018
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 506-563-232# This committee is responsible for developing and executing the ARM strategy and recommendations related to coverage, payment and coding for regenerative medicine products. The committee is ARM’s liaison to CMS, as well as private insurers. ... Details
When: January 9, 2019
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Call-In Information: Phone: 202-602-1295 Access Code: 506-563-232# Developing an ARM Whitepaper: Clarity in Orphan Designation – Definition of “Sameness.” This call will formally initiate the development of an ARM white paper discussing issues related to orphan drug exclusivity and “sameness.” For questions or comments please contact Rob Falb, Director of U.S. Policy and Advocacy... Details
When: January 14, 2019
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Call-In Information: Phone: 202-602-1295 Access Code: 506-563-232# The Regulatory Committee oversees development and implementation of the regulatory agenda for the Alliance. This includes prioritization of regulatory objectives with FDA and others as necessary. The Regulatory Committee is responsible for interaction with regulatory agencies at public hearings, meetings, roundtables, PDUFA negotiations,... Details
When: January 14, 2019
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 421-140-803# This group addresses EU-specific issues and topics related to Health Technology Assessment (HTA), pricing, reimbursement and market access of Advanced Therapy Medicinal Products (ATMPs). Its main objectives are as follows: to establish ARM a resource for our members regarding pricing and reimbursement (P&R) and market access systems and how they work, to help shape the discussions on P&R and market access by ... Details
When: January 27, 2019
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 421-140-803# This group addresses EU-specific issues and topics related to Health Technology Assessment (HTA), pricing, reimbursement and market access of Advanced Therapy Medicinal Products (ATMPs). Its main objectives are as follows: to establish ARM a resource for our members regarding pricing and reimbursement (P&R) and market access systems and how they work, to help shape the discussions on P&R and market access ... Details
When: January 30, 2019
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Desktop Dial-In Information: Phone: 202-602-1295 Access Code: 421-140-803# This committee addresses EU-specific issues and topics related to the regulatory framework of Advanced Therapy Medicinal Product (ATMP) development and manufacture. Its main objectives are two-fold: to contribute consistently and meaningfully to discussions and initiatives to improve the regulatory landscape in the EU, including where appropriate within individual member states and to highlight the... Details
When: January 31, 2019
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