Global regulators gain the most effective means for engaging industry in discussion about the latest technical innovations and current issues through ISPE.
The Society provides a welcoming and neutral environment for industry experts, regulators, technologists, consultants, and members of academia to exchange ideas and gain practical experience.
ISPE is led by individual Members, not companies, who are the world’s top pharmaceutical and biotechnology professionals working together to provide safe, effective, high quality medicines that directly benefit the patient.
Because ISPE does not engage in any lobbying activities and makes no attempt to influence regulations, the Society can play a vital role in assembling experts from its multiple disciplines to design, debate and publicize more effective processes and standards for the ultimate benefit of the patient.
are members of ISPE
How Regulators Can Get Involved
- Participate. Regulators are encouraged to participate in ISPE volunteer groups who are dedicated to leading scientific and technical advancement throughout the entire pharmaceutical lifecycle. Engage in open, nonbinding, neutral dialogue with industry on projects that ultimately improve results for patients.
- Join ISPE as a member: ISPE membership enables regulators to access ISPE’s members-only resources and activities.
Resources for Regulators
ISPE provides complimentary resources to global Regulators that enable them to stay current with the ways industry interprets GMPs, regulations, risk management, and quality systems.
Resources for all regulators:
- ISPE Drug Shortages Prevention Plan
- Pew-ISPE Drug Shortages: An Exploration of the Relationship between U.S. Market Forces and Sterile Injectable Pharmaceutical Products
- Blend and Content Uniformity Tools
Resources for regulator members of ISPE:
- ISPE Guidance Documents
- ISPE Drug Shortage Awareness and Prevention Tool
- ISPE Quality Pilot Program Reports Wave 1 and Wave 2
- Pharmaceutical Engineering® magazine
- Communities of Practice
- ISPE Member Directory
ISPE Membership for Global Regulators/Government Employee
ISPE offers two membership options for regulatory authority/government employees: complimentary membership OR regulatory authority/government employees who are not permitted to receive a complimentary membership can pay $65 USD for an ISPE membership.
Benefits of an ISPE Membership for Regulators:
- Valuable resources:
- Subscription to ISPE’s Pharmaceutical Engineering magazine and the opportunity to publish articles as a means for communicating with industry in a neutral environment
- Access to technical discussions and content through discussions within ISPE’s Communities of Practice. You may either just observe or actively participate. Like all ISPE members, you would be doing so as an individual and not an official.
- Become better known and build rapport with professionals responsible for GMPs, risk management, quality systems, and more.
- Connect at the local level! Dozens of ISPE Affiliates and Chapters around the world offer programs in the local language and provide opportunities that will keep you abreast of the latest happenings in the industry on a regional level.
- Ability to receive customized training for the specific needs of Regulators