September / October 2023

Message from the Chair: Regulatory, One ISPE, and New Leadership

Michael L. Rutherford
Message from the Chair: Michael L. Rutherford

Where has 2023 gone? The year is already three-quarters over. The 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, is just a few weeks away. And I will be passing the gavel to Scott Billman, your next ISPE International Board Chair, at the Membership Luncheon on 16 October.

The Annual Meeting is the largest ISPE conference of the year, with extensive educational tracks, an amazing exposition hall with a wide range of vendors who support our industry, committee meetings, and one of the best opportunities to network and share knowledge with colleagues in your area of interest. If you have not yet registered for the Annual Meeting, please visit the conference website for more details and to register. It is surely going to be an event you don’t want to miss.

Pharmaceutical Engineering® Theme: Regulatory

ISPE has had a long-standing relationship with regulatory agencies around the globe and has played a key role in defining and supporting pharma industry guidance in key technical and regulatory areas. So, the focus of this edition of Pharmaceutical Engineering® should not be a surprise, especially with all of the activities and success in this area. ISPE’s efforts on drug shortages have been ongoing for years and have resulted in new guidance on prevention readiness, released in May 2023, which addresses the evolving international landscape. Thanks to Diane Hustead for her leadership of this effort.

Five guides on Advancing Pharmaceutical Quality (APQ) have been published—Change Management (CM) System, Cultural Excellence, Corrective Action & Preventive Action (CAPA) System, Management Responsibilities & Review (MRR), and Process Performance & Product Quality Monitoring System (PPPQMS)—which furthers the potential for additional efforts in this critical area. ISPE also released a report on its work supporting the establishment of the European Health Emergency Preparedness and Response Authority (HERA), which is available at

The ISPE Harmonization Initiative, “Enabling Global Pharmaceutical Innovation: Delivering for Patients,” led by Roger Nosal has been launched, with the objective to “catalyze consistent and harmonized interpretation and implementation of ICH guidelines.”1 You can learn more about this initiative from the article on page 62. ISPE subject matter experts also participate in multiple regulatory-related initiatives in the US and EU, and ISPE has commented on five regulatory documents as of May. ISPE regulatory efforts are extensive—learn more about them in this edition.

Strategic Plan: One ISPE, Affiliates, and Chapters

When ISPE International launched the One ISPE program with the Affiliates and Chapters, the goals were to enable ISPE to successfully operate its worldwide business, achieve the ISPE vision and mission, provide an operating framework that fosters global growth, and enable synergistic value between ISPE International and the Affiliates and Chapters. As we work through our second year of the program, the success and benefits of the One ISPE program are being realized locally and globally.

I’ve had the opportunity as Board Chair to interact with and participate in regional Affiliate and Chapter events, including, most recently, the face-to-face North American/South America Affiliate Council (NASAAC) meeting in May in Philadelphia, Pennsylvania, US, hosted by the Delaware Valley Chapter as part of their annual Symposium & Exhibition, and the face-to-face Asia Pacific Advisory Council (APAC) meeting in June in Manila, Philippines, hosted by the Philippines Affiliate in conjunction with their 15th Anniversary Conference and Expo.

Both conferences and expositions were very well attended and provided an opportunity to demonstrate how well these Affiliates and Chapters are doing. The regional meetings also highlighted the great work all the Chapters and Affiliates are doing locally to benefit our ISPE members. International Board members, as part of their Affiliate and Chapter Board Liaison roles, and ISPE staff, have also participated in numerous local events around the globe, helping build a better alignment and synergy between the Affiliates and Chapters and ISPE International.

ISPE International and the Board of Directors continue to be committed to our support of One ISPE and the Affiliates and Chapters to foster growth on the global level. With the approval of the Southwest Chapter in May, we welcomed our 40th Affiliate/Chapter in the US. This new chapter will be our host for this year’s Annual Meeting in Las Vegas and is very excited to establish and implement local events to support this new region.

Looking Ahead

Thank you to all of the Affiliate and Chapter leadership and committee volunteers for all of your work and efforts to support the One ISPE program and make these local ISPE organizations successful and beneficial for our members. I look forward to seeing everyone at the 2023 ISPE Annual Meeting & Expo in Las Vegas and our transition to our 2023–2024 leadership at both the international and local level. Viva Las Vegas!

  • 1International Society for Pharmaceutical Engineering. “Enabling Global Pharmaceutical Innovation: Delivering for Patients.”