DC Discussion Group

October 7 15:00 EST | Rockville, MD | Q12 in Practice: PACMP Design, Multi-Regional Execution, and PQS Readiness

Join us in person on October 7 at the DC Discussion Group for an in-depth examination of Post-Approval Change Management Protocols (PACMPs), including protocol design, submission strategy, common regulatory deficiencies, and global implementation considerations. Network with DC-area CASSS members. Registration for this free opportunity closes October 5.

Register for DC Discussion Group

Location:
IBBR (University of Maryland - Institute for Bioscience and Biotechnology Research)
9600 Gudelsky Dr
Rockville, MD 20850

Attendance and Substitution Policy

CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.

Q12 in Practice: PACMP Design, Multi-Regional Execution, and PQS Readiness

Building on earlier discussions on ICH Q12 from the April DCDG program, the session will provide an in-depth examination of Post-Approval Change Management Protocols (PACMPs), including protocol design, submission strategy, common regulatory deficiencies, and global implementation considerations, taking into account the EU's revised Variations Regulation, updated PACMP guidance, and FDA experience. The discussion will also explore the organizational capabilities required for sustainable Q12 adoption, including Q10 maturity, knowledge management, cross-functional engagement, and the growing influence of FDA Quality Management Maturity (QMM) assessments on organizational readiness.

Ingrid Markovic, Novartis Pharmaceuticals Corporation

Ingrid Markovic, Ph.D., currently serves as the Head of Global RA CMC Policy at Novartis GRA CMC where she directs global CMC regulatory policy efforts that significantly impact product development across Novartis' extensive portfolio. Previously she held several positions of increasing responsibility at the FDA, both at CBER and CDER. In her last role at CBER/FDA she led enterprise-level strategy for pharmaceutical quality, CMC policy, and stakeholder engagement across CGTs, Vaccine, and blood product portfolios. She advised CBER executive leadership on opportunities for CMC innovation, emerging trends & challenges, and risk mitigation strategies; including leading cross-agency modernization of post-approval CMC reporting categories for complex biologics. Internationally, she was CBER’s ICH Quality Caucus Lead, Regulatory Chair for ICH Q6, Rapporteur for the Q3E informal EWG, FDA Lead for M4Q, and co-lead for Q12, and QDG. Her academic background includes a Ph.D. from the University of Wisconsin-Madison and postdoctoral training at NIH.

Paresma (Pinky) Patel, Gilead Sciences, Inc. 

Pinky is the Director of Regulatory CMC Policy & Advocacy at Gilead Sciences, where she leads chemistry, manufacturing, and controls (CMC) regulatory advocacy in support of global health authority filings. In this role, she represents Gilead in multiple external forums and advances regulatory policy initiatives, including implementation of ICH M4Q (R2), ICH Q12, and evolving assessment standards.

Prior to joining Gilead, Dr. Patel spent a decade at the U.S. Food and Drug Administration (FDA) (2015–2025), holding positions of increasing responsibility within CDER’s Office of Pharmaceutical Quality. Her roles included Reviewer, Branch Chief, and ultimately Division Director in the Office of Product Quality Assessment III. As Division Director, she led teams responsible for the evaluation of CMC information, with a primary focus on drug substance quality across all stages of development. During her FDA tenure, she also contributed to numerous strategic initiatives and the development of regulatory policies and guidelines.

Earlier in her career, Dr. Patel worked as a medicinal chemist at the National Institutes of Health. She earned her Ph.D. in Organic Chemistry from The Scripps Research Institute (2010) and completed a postdoctoral fellowship at the California Institute of Technology (2012).