Insights
September / October 2024

Message from the Chair: A Look at ISPE Activities - Summer to Fall

Scott Billman
Message from the Chair: Scott W. Billman

I hope everyone had the opportunity to enjoy the summer. The ISPE International Board of Directors and ISPE staff have kept busy through the summer months, launching two new Communities of Practice: Sustainability and Artificial Intelligence.

Both subjects are important and impactful to industry. The leadership for these groups will start to bring together industry leaders in these spaces to discuss the engagement and impact of their respective topics with the pharmaceutical and biotechnology industries. ISPE will look to bring together the experts in these spaces to share knowledge and develop programs for our membership. If you are interested in these areas, reach out and get engaged.

The International Board of Directors had our annual strategic discussion meeting where we reviewed ISPE’s progress against the 2023–2025 Strategic Plan and started to discuss what 2025–2028 could look like for our industry. We focused the discussion on the global aspect of the industry and where ISPE can, and should, play a crucial role. We discussed the current industry trends and the needs in the areas of guidance documents and training.

We also completed the election process and have established the membership for the International Board of Directors that will be installed at the 2024 ISPE Annual Meeting & Expo. Thank you to the members that took the time to evaluate the amazing slate of candidates and cast a vote.

I hope you will take advantage of the various events, topics, and speakers at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, this year. I invite everyone to attend our ISPE Membership Meeting & Awards Lunch while you are there. I will be recapping the last year of ISPE activities, and you will hear from other ISPE leaders and colleagues about advances in our industry. We will also be celebrating our dedicated volunteers during the Annual Honor Awards ceremony during the membership lunch. The conference will end on Wednesday, but stick around and join us for the Annual ISPE Foundation charitable golf tournament that afternoon.

Thank you to the members that took the time to evaluate the amazing slate of candidates for the ISPE International Board of Directors and cast a vote.

This issue of Pharmaceutical Engineering® is focused on the regulatory and quality aspects of the industry. ISPE has an extensive portfolio of regulatory initiatives and interactions with global health authorities in areas such as quality management maturity (QMM), the practical application of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines, and drug shortage prevention. Our Regulatory team also published the results of the Enabling Pharmaceutical Innovation: Delivering for Patients - A Report on the Barriers to Innovation Survey this summer.

Join us at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, 13–16 October.

This issue includes an overview of the regulatory Q&A from the Aseptic Conference. A full transcript of the Q&A is available online at ISPE.org. You will also find articles around harmonization efforts in Latin America and a summary of the ISPE survey on harmonization. We have articles from across many of the ISPE volunteer groups. Members of the Regulatory Quality Harmonization Committee, Product Quality Lifecycle Implementation® Commit-tee, Process Validation Team, Regulatory Steering Council, GAMP® CoP, and Combination Products CoP all contributed to the articles. I am continually impressed with the quality and content of the articles and technical trainings that these volunteer teams produce. It is a true testament to the dedication of the ISPE membership and their deep industry knowledge.

I look forward to engaging with the membership at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida. I hope to see you there.