Partnership For Dscsa Governance Inc Pdg

THE PURPOSE OF THE ORGANIZATION IS TO PROMOTE THE COMMON BUSINESS AND PROFESSIONAL INTERESTS OF THE MEMBERS TO ADVANCE THE EFFECTIVE AND EFFICIENT IMPLEMENTATION OF THE DRUG CHAIN SUPPLY CHAIN SECURITY ACT (DSCSA) REQUIREMENTS FOR ELECTRONIC INTEROPERABLE VERIFICATION AND TRACING OF CERTAIN PRESCRIPTION DRUGS AND TO HELP SAFEGUARD THE SUPPLY OF PHARMACEUTICAL DRUGS IN THE US THROUGH THE EFFECTIVE AND EFFICIENT IMPLEMENTATION OF THE PROVISIONS OF THE DSCSA INCLUDING THE IMPLEMENTATION OF THE TRACEABILITY PROVISIONS OF THIS LAW.

THE PRIMARY ACTIVITIES OF PDG WILL BE EXECUTION OF THE SUBSTANTIVE, TACTICAL, AND TECHNICAL WORK NEEDED TO ESTABLISH AND ADVANCE A BLUEPRINT FOR INTEROPERABILITY, AS REQUIRED BY THE DSCSA, THE PRIMARY OBJECTIVES ARE: (1) DEVELOPMENT AND EXECUTION OF AN FDA-APPROVED PILOT ON DSCSA INTEROPERABILITY GOVERNANCE, AND (2) DEVELOPMENT AND PUBLICATION OF A BLUEPRINT FOR INTEROPERABILITY. SPECIFICALLY, SUCH PDG OUTPUTS INCLUDE: - DEVELOP A STRATEGY AND WORK PLAN THAT INCLUDES: O AN EXPLANATION/DEFINITION OF WHAT CONSTITUTES A "BLUEPRINT-; O A STRATEGY FOR HOW THE COMPONENTS OF A BLUEPRINT WILL BE SEPARATED AND ADDRESSED; O A COMMITTEE MEETING SCHEDULE; AND O KEY INTERIM MILESTONES THAT MUST BE ACHIEVED TO DEVELOP AND PUBLISH A BLUEPRINT ON TIME. - DEVELOP AND PUBLISH A BLUEPRINT FOR INTEROPERABILITY. UPON PUBLICATION OF PDG'S BLUEPRINT FOR INTEROPERABILITY, PDG WILL UNDERTAKE COLLABORATIVE CROSS-INDUSTRY EFFORTS NEEDED TO SUPPORT THE IMPLEMENTATION OF THAT BLUEPRINT TO ACHIEVE COMPLIANCE WITH THE DSCSA.