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Race to the finish: pharma edges closer to approval with RSV vaccines

Pharmaceutical Technology

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

QMM encompasses a range of actions including metrics, leadership commitment, culture, sustainable compliance, enhanced pharmaceutical quality systems, continual improvement, and risk management. QMM rating program is necessary to ensure patients have consistent access to the drugs they need. Next Slide ??. Michael Kopcha. Thomas Wozniewski.

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How early planning leads to successful market access and drug launch in Europe

Pharmaceutical Technology

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. In Europe, the pricing and reimbursement (P&R) of pharmaceuticals is governed by individual member states.

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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

OCC Guidelines Establishing Heightened Standards for Certain Large Insured National Banks, Insured Federal Savings Associations, and Insured Federal Branches; Integration of Regulations.” Supply Chains of Quality Pharmaceuticals.” Office of Pharmaceutical Quality (OPQ) White Paper. Final Rule.