Reigniting PDA Puerto Rico A New Era of Science, People & Regulation

In June 2024, the PDA Puerto Rico (PR) Chapter embarked on an ambitious journey to reactivate and strengthen its presence within the global PDA network. Guided by a renewed vision for 2024–2026, the Chapter aims to grow membership, foster education, build networks, and develop leadership in pharmaceutical and biopharmaceutical science and regulation.

A Renewed Mission

The Chapter’s mission remains deeply aligned with PDA’s global purpose — to advance pharmaceutical and biopharmaceutical manufacturing science and regulation, empowering members to better serve patients through innovation, quality, and collaboration. This renewed focus has set the stage for a new era of growth, engagement, and impact within the Puerto Rican life sciences community.

Milestones and Progress

Since the reactivation began, the Chapter has achieved remarkable progress. By mid-2025, it had successfully executed two major events and begun planning a third, each advancing the Chapter’s educational and networking goals.

Event 1: Speed to Patients — Accelerating Innovation in the Pharmaceutical Industry

Held on February 25, 2025, this half-day event explored how innovation and agility can bring medicines to patients faster. The discussions revolved around four key themes:

• Quality in aseptic processing as a cornerstone of patient safety.
• Agility in technology transfer to improve efficiency.
• Regulatory levers that enable accelerated approvals.
• Technology as an enabler of speed and operational excellence.

With 130 attendees, including 30% PDA members, the event generated strong participation and enthusiasm. Backed by 13 sponsors and seven speakers, the event achieved impressive financial success, with net income of $15,832. The session concluded with a high-impact panel discussion that showcased real-world case studies and strategies for accelerating patient access to therapies.

Event 2: Annex 1 PUPSIT Implementation — Industry Perspectives

The second event, held on July 18, 2025, was an exclusive, invitation-only full-day session hosted at BMS facilities. Focused on Annex 1 PUPSIT (Pre-use Post-Sterilization Integrity Testing), it gathered 50 industry professionals, all PDA members, to discuss compliance strategies and practical implementation challenges.

The program featured 13 speakers, including global experts and a PDA paper author, who shared valuable insights into balancing regulatory expectations with real-world manufacturing constraints.

Key elements included:

• Deep-dive discussions on scientific principles and regulatory expectations.
• Interactive panels on execution risks and compliance challenges.
• A collaborative workshop where participants applied knowledge and explored practical solutions.

With strong sponsor support and efficient event management, the Chapter reported $6,000 in net income. Participant feedback was overwhelmingly positive — every attendee rated the event a perfect 5 out of 5, underscoring its exceptional educational value.

Upcoming Event: Building Supply Chain Resilience to Prevent Drug Shortages

The Chapter’s next major event is scheduled for November 13, 2025, at the San Juan Marriott Hotel. Designed as a full-day conference with an expected 200 participants, it will focus on preventing drug shortages and promoting supply chain resilience across the pharmaceutical landscape.

Planned highlights include discussions on:

• Supply chain and infrastructure resilience
• Quality and regulatory considerations
• The role of technology in ensuring continuity of supply

With more than 10 confirmed speakers and strong sponsor interest, the Chapter anticipates this event will become one of the most impactful gatherings of the year.

Impact and Recognition

Feedback from the first two events has validated the Chapter’s renewed direction:

• “Speed to Patients” received an average rating of 4.6/5, with 86% of attendees giving the highest score.
• “Annex 1 PUPSIT” achieved 100% top ratings, confirming its exceptional quality and relevance.

These results demonstrate the Chapter’s ability to deliver high-value educational experiences and meaningful industry connections.

Looking Ahead

The PDA Puerto Rico Chapter is now firmly reestablished — stronger, more engaged, and deeply committed to its mission. As it continues to expand its reach and offerings, the Chapter stands as a vital platform for professionals to exchange knowledge, collaborate on regulatory and technical challenges, and ultimately advance pharmaceutical innovation for the benefit of patients worldwide.