Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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Page 16 of 75

PDA: Shaping the Global Regulatory Landscape PDA lives its motto – Connecting People, Science, and Regulation ® – every day through our engagement with health authorities and pharmacopeias around the world. In harmony with our consensus-driven, peer-reviewed Technical Reports, PDA members collaborate in Commenting Teams to develop responses to draft regulations and guidances that refl ect our vision of maximizing product quality, availability, and value. • We advocate for global harmonization, simplifi cation, and effi ciency in the regulations that impact the manufacturing science of pharmaceuticals, biopharmaceuticals, and advanced therapies. Harmonization of regulatory requirements—in both text and application—can drive innovation, quality performance, and compliance. • We help guide regulators on emerging science and technology topics. As the industry continues to shift from traditional pharmaceuticals and biologics to novel therapies, and as manufacturing technology advances, PDA can identify and help health authorities resolve real-world implementation questions before they impact patients. PDA is uniquely positioned to help regulators create workable and innovative regulatory solutions that protect product quality and availability. With more than 10,500 members and 26 chapters globally, PDA can gather diverse perspectives on regulatory initiatives, and can connect regulators and experts on topics that impact manufacturing science. PDA succeeds because of the hard work, determination, and diversity of its volunteers and members. As a PDA member, you are invited to participate in our commenting teams. To fi nd out how: • Explore our volunteer opportunities at • Visit to join one of our Interest Groups PDA's past regulatory comments are on our website at

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