9:15am – 10:15am PT

Challenges and Strategies of Combination Product Regulatory Pathway

Presenters:

James Bertram, Director, Office of Combination Product

Stephanie Shapley, Senior Advisor, Office of Combination Product

The Role of Real-World Evidence in Supporting Medical Device Regulatory Submissions

Presenters:

Felipe Aquel, Deputy Director, Office Clinical Evidence and Analysis, FDA/CDRH

Tyson Rogers, Principal Strategy Consultant, Biostatistics, NAMSA

Program Synopsis & Learning Objectives: 

The last 10 years have seen rapid development in the availability and use of real-world data (RWD) for development of real-world evidence (RWE). The acceptance of real-world data for regulatory purposes depends on both the data being fit-for-purpose and the use of appropriate analysis methods to limit potential biases in the generation of evidence. As experience with RWD/RWE has matured, regulatory applications have expanded substantially. As a sign of that maturation, FDA’s CDRH released a draft update to the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” guidance document in December 2023. With ever-expanding options for both data sources and methods, it can be challenging to chart an efficient course toward FDA acceptance of RWE for your particular regulatory objective. This presentation will provide an overview of the current RWD/RWE landscape and highlight recent developments in available methods for translating real world data to real world evidence, with a focus on regulatory applications.

1. Identify relevant sources of real-world data

2. Understand key elements necessary to demonstrate that real-world data is fit-for-purpose

3. Identify biases that can impact real-world evidence and select appropriate methods to address them

10:30am – 11:30am PT  

The Latest Updates, Challenges, and Strategies for EU IVDR Compliance

Presenter: Marta Carnielli, PharmD, Head of Certification IVD, TÜV SÜD

Program Synopsis & Learning Objectives:

Although the EU In-Vitro Diagnostics Regulation (IVDR) is applicable since 26 May 2022, the transition is still in progress. This is due to several factors including, but not limited to, the delayed availability of some element of the regulatory infrastructure; for many IVD manufacturers, the IVDR certification process represents the first interaction with a notified body. This presentation will provide an overview of the transition status including the latest deadlines and the status of the implementation of reference laboratories. A review of the steps of the conformity assessment process with a notified body, of the lesson learned and of available resources will also be included. The presentation will include a Q&A session to allow participants sufficient time to ask questions.

By attending this presentation, participants will:

1. Gather an up-to-date view of the status of the transition to the IVDR

2. Gain knowledge of the various steps of a conformity assessment process under the IVDR

3. Learn about the most commonly observed pitfalls in the IVDR conformity

assessment process.

IVDR Implementation – An Industry Perspective

Presenter: Annette Hellie, Sr. Manager Global Regulatory Affairs, Beckman Coulter

Program Synopsis & Learning Objectives: Industry perspective of IVDR implementation and sustainment:

1. High level IVDR process steps for implementation

2. Considerations in selecting a Notified Body

3. Planning for current and future product portfolio

IEC 60601-1 4th Edition – Changes, Challenges, and What to Expect

Presenter: Ayub Yancheshmeh, Co-convenor of Fire & Thermal Hazards for IEC 60601-1 4th edition project; Sr. Staff Standards and Compliance Engineer, BD

Program Synopsis & Learning Objectives:

IEC 60601-1 4th edition, changes, and challenges and what to expect.

1. The new structure of IEC 60601-1

2. Design specification

3. New topics

4. How to get involved

12:30pm – 1:30pm PT 

Computational Modeling and Simulation in Regulatory Submissions

Presenter: Kristian Debus, PhD, Chief Commercial Officer, Virtonomy

Program Synopsis & Learning Objectives:

1. Role of in silico technologies in medical device regulation

• Computational modeling and simulation for safety and effectiveness

• Acceptance of in silico evidence by global regulators

• Generating digital evidence through virtual patient cohorts and simulations

2. Benefits of virtual simulations in medical device development

• Accelerating development through rapid design iteration

• Reducing reliance on animal and clinical trials

• Integrating virtual data into regulatory submissions

3. Meeting safety and efficacy standards with in silico technologies

• Generating robust digital evidence

• Incorporating virtual patient populations and simulations

• Streamlining the regulatory approval process

Presenter: Abie Ekangaki, PhD, VP, Statistical Consulting, Premier Research

Program Synopsis & Learning Objectives: 

1. Recognize those challenges of clinical trials that justify use of digital patients in trials for regulatory approval of new treatments.

2. Understand the general framework for constructing in silico synthetic patients for use as control arm of clinical trials.

3. Insights on recently published and evolving guidelines for in silico modeling and simulation necessary to ensure credibility of these approaches for regulatory submission.

1:45pm – 2:45pm PT

Artificial Intelligence in Medical Devices – Regulatory Considerations 

Presenters:

Philip Desjardins, JD, Partner, Arnold & Porter

FDA Digital Health Center of Excellence (DHCoE) speaker

Program Synopsis & Learning Objectives:

This presentation delves into the pivotal role of the FDA in shaping AI’s role in life sciences. Exploring FDA’s regulatory framework for AI, we analyze its approach to AI-based medical devices and algorithms, emphasizing Predetermined Change Control Plans (PCCPs). We scrutinize FDA’s guidance on clinical decision support software and examine its categorization of AI-driven medical solutions. Additionally, we provide insights into effective strategies for regulatory compliance and proactive engagement with regulatory agencies. This presentation offers a comprehensive understanding of navigating the regulatory landscape, ensuring safe and effective integration of AI in medical devices.

1. Understand the pivotal role of the FDA in shaping the integration of artificial intelligence in medical devices within the life sciences industry.

2. Analyze the FDA’s regulatory framework for artificial intelligence, focusing on its approach to regulating AI-based medical devices and algorithms.

3. Evaluate the importance of Predetermined Change Control Plans (PCCPs) in ensuring regulatory compliance and effective management of AI-driven medical devices.

4. Examine the FDA’s guidance on clinical decision support software and its implications for developers and manufacturers of AI-driven medical solutions.

5. Develop strategies for proactive engagement with regulatory agencies and ensuring compliance with evolving regulatory standards for the safe and effective integration of AI in medical devices.

3:00pm – 4:00pm PT 

Advertising and Promotion in Medical Device

Presenter: Melissa Hoffman, VP, Regulatory Counsel TMTT at Edwards Lifesciences

1. Updates within the OBIMO program and
2. What to expect when being inspected

4:15pm – 4:50pm PT 

Closing Plenary

Leaders’ Insight: Data Integrity and Its Impact on Product Approval

Panel Speakers:

Je Hi An, Ph.D., Sr. Director, Regulatory Affairs Strategy – Device Aesthetics, AbbVie

Anjali Malhotra, DRSc, MBA, CQA, CCS, CG (ASCP), SVP, Clinical Development & QA, ImmunityBio, Inc.

FDA National Expert Speaker

4:50pm – 5:00pm PT

Closing Remarks

Presenters:

Fawn Zhang, PharmD, JD, OCRA-DG President

Binh Nguyen, PharmD, , MS Reg Sc, BCSCP,  FHPE, OCRA-DG Annual Conference Chair