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PD
NGOPDA

Parenteral Drug Association

Bethesda, UNITED STATESNot for profit legal associationReg: 894106921549-04Since 27/04/2016

Budget

€2,372,986

EP Access

0

accredited persons

Staff

8

2 FTE

EU Grants

None

Mission & Goals

The Parenteral Drug Association (PDA) is the leading global facilitator of science, technology and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers education for the community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical / biopharmaceutical manufacturing science and regulation so members can better serve patients. PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology. MISSION: To advance pharmaceutical / biopharmaceutical manufacturing science and regulation so members can better serve patients.

EU Legislative Interests

Directive 2001/83/EC and related EMA scientific guidelines Rules Governing Medicinal Products in the EU (Eudralex) Volumes 1,4,5 (medicinal products, veterinary products, good manufacturing practices), including Annexes CHMP Quality Guidelines Directive 2001/62/EU (Falsified Medicines) Regulation(EC) No 1394/2007 (Advanced Therapies)

Communication Activities

PDA follows and responds to the publications of EMA, EDQM, DG Sante, National Health Authorities, and PIC/S in areas related to pharmaceutical manufacturing such as: Advanced Therapies, Active Pharmaceutical Ingredients, Aseptic Processing, Drug Shortages, Data Integrity, Good Manufacturing Practices, Medicinal Products, Microbiology, Sterilisation and Visual Inspection.

Interests Represented

Does not represent commercial interests

Member Of

RX 360 http://rx-360.org/en-us/ Product Quality Research Institute http://pqri.org/ Partnership for Safe Medicines United States Pharmacopeia http://www.usp.org PDA does not have established a PDA webpage, which lists the links to organizations, where PDA is a member.

Organisation Members

PDA has no organizations which are member of PDA. PDA does not have organizational members. Membership is retained by individuals.

Commissioner Meetings

No recorded meetings with EU commissioners.