International Society for Pharmaceutical Engineering
Acronym: ISPE
General Information
Identification Code: 316626227774-56
Website: [object Object]
Entity Form: not for profit legal association
Registration Category: Trade and business associations
Registration Date: 8/2/2017
Last Update: 5/29/2024
EP Accredited Number: 0
Mission & Interests
Goals: The International Society for Pharmaceutical Engineering (ISPE) is a nonprofit association serving its members by connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients. ISPE's members are pharmaceutical professionals who use expert knowledge to create high-quality, cost-effective GMP solutions. All scientific and technical areas of the pharmaceutical manufacturing industry are represented among the ISPE Membership.
The Society’s Guidance Documents are relied upon globally by industry for design, construction and operation of pharmaceutical manufacturing facilities. ISPE’s training, conferences and Knowledge Networks give professionals solutions for their needs and connect them with other professionals to share best practices.
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
- Business and industry
- Education and training
- Public health
- Research and innovation
Levels of Interest:
- global
Activities
Main EU Legislative Proposals: ISPE follows and responds to the publications of the EC, EMA, EDQM, National Competent Authorities, and PIC/S in areas related to pharmaceutical manufacturing such as: Advanced Therapies, Active Pharmaceutical Ingredients, Aseptic Processing, Drug Shortages, Data Integrity, GMPs, Medicinal Products, Digital Transformation, Sustainability, and Quality. ISPE has spoken on behalf of its membership and provided scientific insights at the invitation of the EMA Inspectors Working Party. Expert group members speak at ISPE conferences.
Communication Activities: ISPE’s professional activities include contributions to EMA groups such as the Inspectors’ Working Party, Quality Innovation Group, and the EMA initiative on Drug Shortages. ISPE maintains an active website, comments on draft scientific guidelines such as those published by the EMA, and publishes a wide range of best-practice guides for members. Additionally, ISPE offers training programmes for both industry and regulatory agencies.
Inter-institutional or Unofficial Groupings: Artificial intelligence and digital
Head Office
Address: 6110 Executive BlvdSuite 600
Post Code: 20852
City: Rockville
Country: UNITED STATES
Phone: [object Object]
EU Office
Address: 6110 Executive BlvdSuite 600
Post Code: 20852
City: Rockville
Country: UNITED STATES
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Membership Information
Members10 Percent: 7
Members25 Percent: 1
Members50 Percent: 0
Members75 Percent: 0
Members: 10
Members F T E: 2.950000047683716
Info Members: A large number of ISPE members throughout the world contribute small amounts of their time to a variety of global and regional subjects. The assessment of persons therefore includes both staff and volunteer members who represent ISPE to the various European bodies, who submit comments to draft documents originating in Europe.
Headquarters, the European staff members, and elected volunteer members provide support to more than 22,000 members globally representing, for example, owner companies, contract organisations, suppliers and regulators. ISPE is committed to the interests of patients, supporting key EMA initiatives such as the drive to reduce drug shortages. The Society also organises conferences, meetings and training courses that use the scientific strength and depth of its membership to advance pharmaceutical and manufacturing science and technology.
Structure
Structure Type: Structure
Is Member Of: Not applicable.
Organisation Members: ISPE participates in a group of associations comprised of A3P Association, AnimalhealthEurope, Association of the European Self-Medication Industry (AESGP), ECA Foundation, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Industrial Pharmacists Group (EIPG), European QP Association (EQPA), Medicines for Europe, Parenteral Drug Association (PDA), Pharmaceutical and Healthcare Sciences Society (PHSS) and Vaccines Europe. The group acts as interested parties in communication with the EMA GMP/GDP-IWG.