Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products

The field of generic ophthalmic drug products is rapidly evolving, with increasing complexity in drug product formulations and devices, leading to challenges in assessing performance sameness and ensuring quality. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic development and regulatory assessment.

Attendees will gain valuable insights into the intricacies of developing ophthalmic products, including insertable, implantable, and topical ophthalmic therapies. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, academia and regulatory agencies in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends.

Specifically, the two-day workshop will cover critical issues such as in vitro drug release testing, qualitative (Q1) and quantitative (Q2) sameness of complex ingredients in ophthalmic products, formulation characterization, considerations for clinical bioequivalence studies, and the challenges encountered when developing or assessing prospective generic ophthalmic products.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)

In-person Attendees will enjoy all the benefits of virtual attendance as well as interactive experiences featuring:

• Interactive Small Group Working Sessions on key topics related to generic ophthalmic drug products, such as compositional sameness, bioequivalence demonstration strategies, drug release testing, quality, and devices, with FDA, industry, and academic experts.
• Collaborative Problem-Solving Exercises, including real-world case studies and consensus mapping to identify priorities and actionable outcomes.
• Direct Interactions with experts from industry, academia and FDA for clarifying regulatory expectations and exploring regulatory standards insights.
• Networking Opportunities designed to foster partnerships and advance regulatory science for complex ophthalmic generics.

Workshop Topics

• Regulatory Standards and Bioequivalence Approaches for ophthalmic solutions, suspensions, emulsions, inserts, and combination products.
• Qualitative and Quantitative Sameness and Formulation Challenges, including case studies on excipient changes, sterilization effects, and polymeric systems.
• Advanced In Vitro Testing and Modeling, such as IVRT method development, CFD-PBPK modeling, and predictive release strategies.
• Quality and Risk Considerations, focusing on sterility assurance, particulate control, and container-closure considerations for ophthalmic products.
• Regulatory Strategies for Ophthalmic Drug-Device Combination Products, addressing human factors, comparative threshold analysis, and lessons from complex ANDA submissions.

Audience

The workshop is designed for professionals interested in advancing their understanding of regulatory science and bioequivalence strategies for complex ophthalmic drug products. It is ideal for individuals working in the development, quality, and regulatory evaluation of ophthalmic solutions, suspensions, emulsions, implants, and drug-device combination products. This includes formulation scientists, analytical scientists, regulatory affairs specialists, quality control experts, and R&D professionals from industry, academia, and government.

• Virtual Attendance is ideal for those who wish to access expert presentations and panel discussions remotely, eliminate travel requirements, and have the flexibility to engage with content in real time or on demand.
• In-Person Attendance is best for participants seeking high-level engagement through collaborative small group working sessions, direct interaction with experts from industry, academia and FDA, and immersive learning focused on real-world challenges and problem-solving.

Registration Fees:

• This workshop is FREE for virtual attendees.

• The combined cost for the two-day workshop in-person attendance and activities is:
  • $350, in-person attendees – general
  • $150, in-person attendees – government (must have an email ending in “.gov” to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included.  A link to order lunch for each day of the workshop and instructions will be sent closer to the dates of the workshop.

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance.  Other students, please email CRCG for a reduced rate.  Contact CRCG at (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending the workshop in-person, when requested.

Introduction to the Workshop

This two-day hybrid workshop will explore the evolving landscape of generic ophthalmic drug products, where increasing formulation complexity and innovative delivery systems present unique challenges for ensuring therapeutic equivalence and quality. Designed as a collaborative platform, the workshop brings together FDA scientists, industry leaders, and academic experts to share knowledge, discuss regulatory expectations, and identify research priorities that support safe, effective, and affordable ophthalmic generics.

Participants will gain critical insights into formulation sameness, physicochemical characterization, bioequivalence strategies, and quality considerations for ophthalmic solutions, dispersions, inserts, implants, and drug-device combination products. Sessions will feature expert presentations, case studies, and interactive panel discussions.

In-person attendees will benefit from small-group working sessions focused on real-world challenges, best practices, and actionable solutions, offering a unique opportunity for direct engagement with regulators and thought leaders from industry and academia.

DAY 1:

Session 1: Ophthalmic Product Standards and General Bioequivalence Considerations

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session provides a regulatory and scientific foundation for establishing bioequivalence in ophthalmic drug products. Topics include the impact of FDA research on ophthalmic drug development, Q3 characterization, and challenges with compositional sameness. Experts will discuss the influence of formulation changes such as preservative substitutions, regulatory expectations for in vitro release testing, and strategies for addressing scientific hurdles in ANDA submissions.

Session 2: Regulatory Science Applied to Ophthalmic Dispersion Products

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• Focusing on ophthalmic dispersions and suspensions, this session examines in vitro and in vivo bioequivalence approaches, pharmacokinetic/pharmacodynamic assessment, and modeling frameworks to support generic product development. Speakers will present case studies and practical considerations, including common deficiencies and innovative regulatory science tools for bioequivalence evaluation.

Session 3: Small-Group Working Sessions

Format: Interactive Working Session Part 1 (In-Person Attendees Only)

• In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-Person Attendees will engage in discussions and exercises related to Q1/Q2 sameness, physicochemical characterization, IVRT method development, quality considerations, and drug-device combination products within the scope of ophthalmic products. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations. Direct interactions with experts from FDA, industry, and academia will be fostered.

DAY 2:

Session 4: Regulatory Science Applied to Ophthalmic Insertable and Implantable Products

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session explores advanced regulatory science considerations for long-acting ophthalmic products such as inserts and implants. Experts will discuss performance characterization, analytical strategies for polymeric systems, reverse engineering approaches, drug product characterization, bioequivalence, and in vitro/in silico predictive methods. Additional topics include quality challenges and best practices for ensuring consistent product performance.

Session 5: Regulatory Science Applied to Ophthalmic Drug-Device Combination Products

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• The final hybrid session focuses on regulatory and technical challenges associated with ophthalmic drug-device combination products. Topics include comparative threshold analysis, device usability testing, lessons learned from ANDA submissions, and quality considerations for delivery systems. Both FDA and industry perspectives will inform strategies to navigate this evolving space effectively.

Session 6: Small-Group Working Sessions

Format: Interactive Working Session Part 2 (In-Person Attendees Only)

• In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-Person Attendees will engage in discussions and exercises related to Q1/Q2 sameness, physicochemical characterization, IVRT method development, quality considerations, and drug-device combination products within the scope of ophthalmic products. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations. Direct interactions with experts from FDA, industry, and academia will be fostered.