ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
Navigating through ATMP Guidance and Regulations
It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. A session at the ISPE Europe Annual Meeting in May 2025 revealed how to navigate through some of these differences. Read More
Regulators Discuss Embracing Digital Transformation and Technology in an Evolving Landscape
Regulators from the European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), and the Austrian Agency for Health and Food Safety (AGES) addressed key areas shaping the future of pharmaceutical oversight, including data management strategies, future regulatory collaboration, and the impact of AI/ML on pharmaceutical regulation at the ISPE Europe Annual Meeting in May 2025.
Navigating Global Oversight: A Report from the 2025 ISPE China Conference
At the ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products Supervisor at the USFDA’s China Office, delivered a comprehensive update on the agency’s regulatory and inspectional activities. His presentation offered a detailed look at the FDA’s evolving global strategy, with a particular focus on China’s role in the pharmaceutical supply chain. Read More
The Power of a United Voice: How ISPE Members Can Help Shape Regulatory Guidance
When health authorities release drafts of new regulation and guidance for public comment, anyone is free to share their thoughts as an individual. But there is power in speaking with a united voice. ISPE leverages members expertise to prove input on draft regulations and guidance for maximum benefit to industry, regulators and patients. Read More
ISPE Regulatory Volunteer Spotlight: Tami Frederick
Tami Frederick is Senior Director, Corporate Quality at Perrigo Company plc. In ISPE, Tami leads ISPE’s Advancing Pharmaceutical Quality (APQ)™ initiative, a position she has held since 2019. During her tenure, the team created the Advancing Pharmaceutical Quality™ Program, an industry-led quality management maturity program based on ICH Q10 plus Cultural Excellence. While developing the APQ Program the team published numerous articles in Pharmaceutical Engineering magazine, numerous blogs, conducted several webinars, presented many conference sessions, presented at an FDA advisory panel, and held collaborative workshops with FDA colleagues. When asked what she found rewarding about her work with ISPE, Tami noted that she enjoys collaborating with industry experts, and that mentoring future leaders on the importance of the QMS and how they can continuously improve has been a highlight. She values the network of amazing industry leaders that have become good friends, appreciates the collaboration and recognition by FDA and international regulators during development, piloting, training, and demonstrated use of the APQ program. In 2023 the APQ Team was named ISPE’s Committee of the Year in recognition of their work which has been instrumental in raising ISPE’s profile with global regulators as a critical thought leader in the pharmaceutical industry. In her free time, Tami enjoys traveling, swimming, music, and new adventures with family and friends.
The ISPE Advancing Pharmaceutical Quality (APQ) program is available as series of guides and a training course.
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.