Message from the Chair: Signs of the Times

Joanne R. Barrick, RPh

I used to think “home detention” was no punishment at all, but this last year has dramatically changed my thinking. Despite working from home for over a year, my house is a wreck! Like many of you, I feel busier than ever, despite not traveling and not driving to and from work. Disruption used to be rare and now it is common: having to adapt to new ways of doing most everything, like buying groceries, seeing a doctor, collaborating on work projects, teaching classes, and socializing.

Data accuracy and security are two areas impacted by the disruptions we are experiencing. Recently, I received three personal data breach security alerts in one day. I receive numerous phone calls telling me I owe money to the IRS, that my loan has been approved, there is suspicious activity on my credit cards, and even an email telling me $5,000 gaming systems have been purchased through my Amazon account. These events reinforce the importance of two of the many facets of our ISPE GAMP® initiatives.

Celebrating GAMP^®

We are proud that the ISPE GAMP^® Community of Practice (CoP) celebrates its 30th anniversary this year. The Community of Practice now has 4,626 members, making it the third largest ISPE Community of Practice Throughout its 30 years, GAMP^® has strived to disseminate knowledge and guidance that supports a pragmatic, patient-centric approach to computerized system quality. GAMP^® has significantly benefited industry by driving a risk-based response to quality and regulatory requirements. The GAMP^® Community of Practice has global representation from all corners of Europe to North America, Brazil, Japan, India, Asia Pacific, and most recently, Turkey.

GAMP^® has a philosophy of enabling innovation by adopting modern practices and advanced automation and applying critical thinking that in turn enhances operational performance and quality throughout the product life cycle. Through an extensive range of Special Interest Groups (SIGs), GAMP^® is currently addressing the use of Agile development frameworks, artificial intelligence, alignment with the US FDA CDRH Case for Quality, blockchain use cases, data integrity, and many other exciting avenues that will benefit the global life sciences sector.

We make decisions impacting patients every day based on data, and if the data isn’t accurate, neither are our decisions. GAMP^® publishes invaluable guidances, and GAMP^®-based training classes continue to be some of ISPE’s most popular offerings. My sincere appreciation and congratulations go to Heather Watson, GSK, Global Chair of the Community of Practice, and the entire GAMP^® Steering Committee and organization for continually outstanding work over 30 years.

Collaboration Continues

Another sign of the times is that we continue to see unprecedented collaboration in the pharma industry between companies, regulators, academics, and supply chain. I recently saw an announcement from two companies that are combining their independently developed monoclonal antibodies (mAbs) into one product in an effort to provide a more effective treatment for COVID-19 and combat virus variants. I am so inspired and proud of the way our industry has quickly worked together toward ending the threat posed by this terrible disease.

Effective collaboration is also exhibited by our ISPE Chapters and Affiliates. In recent Regional Council meetings, I was amazed at the level of openness in sharing lessons learned, topics of interest, and invitations to attend each other’s events. Here are just a few notable achievements/activities:

Offerings for students and Emerging Leaders, such as hackathons, are expanding at several Chapters and Affiliates. This is a great step toward attracting young and diverse talent to our industry at a time when public awareness of the value of our industry may be at an all-time high.
Our France Affiliate has held an event focused on distance assessment and several GAMP^® workshops.
Our new Eurasia Affiliate recently held an event with over 1,000 participants.
The Asia-Pacific Region (APAC) has established an Action Tracker and collaboration website, demonstrating impressive flexibility and adaptability.
Many Chapters and Affiliates have their own Community of Practices and Women in Pharma® (WIP) activities.
The Japan Affiliate has invited those in Asia-Pacific Region to attend the first day of their annual meeting in May, which will be presented in English.
The Boston Chapter has started a diversity and inclusion initiative.

I’d also like to highlight one of our newest opportunities for collaboration: the Virology Special Interest Groups. I anticipate there will be very significant interest, and I am looking forward to learning more.

It won’t be much longer until we are all out of “home detention,” and I look forward to collaborating and celebrating face to face with many of you at future ISPE events. In the meantime, stay safe!

GAMP® Initiatives

GAMP®