PDA Combination Products Workshop 2024

Breaking Boundaries: Faster, Better, Smarter

Phoenix, AZ
42 days left to save!
Ask a Question

Master the essentials of combination products and medical devices at the PDA Combination Products Workshop 2024!

This program is customized to guide you through the entire lifecycle of combination products and medical devices, with a focus on critical development activities. Get equipped with essential knowledge and practical skills in areas including risk management, verification and validation, preparation for submission readiness, manufacturing and technology transfer best practices, and change management.

Engage in interactive case studies that apply knowledge to real-world scenarios. Hone your skills through practical applications and acquire unparalleled insights into navigating regulatory frameworks across diverse regions. Learn how to implement new strategies to your own processes to propel your organization’s success to new heights.

This workshop is ideal for professionals involved in the development/engineering, regulatory affairs, quality assurance, lifecycle management, and manufacturing of combination products and medical devices. Whether you are new to the field or seeking advanced insights, this comprehensive workshop will provide valuable knowledge and tools for success in the industry.

Secure your spot today to embark on this enriching experience to master combination products excellence!

PROGRAM PLANNING COMMITTEE

  • Maggie Bandel, Johnson & Johnson (Chair)
  • Flora Felsovalyi, Lonza
  • Akshay Kamdar, Eli Lilly and Company
  • Lee Leichter, P/L Biomedical

Early Registration

Register by 28 August 2024

Member Price

$1,595

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$1,995

Standard Registration

Register after 28 August 2024

Member Price

$2,095

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$2,395

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Wednesday, 23 October MDT

 

Thursday, 24 October MDT

  • Continental Breakfast

  • Registration Open

  • P1: Navigating the Complexities of Risk Management for Combination Products

    • Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    Join us for an in-depth exploration of risk management complexities specific to combination products. This session will provide strategies for ensuring the safety and efficacy of these innovative therapies, drawing from key guidelines including AAMI TIR 105, ICH Q9, and ISO 14971. We will address system risks, with a particular focus on the interactions between drugs and devices. Experts will share their expertise, offering practical guidance and real-world examples to help you navigate the complexities of risk management for combination products. Enhance your understanding and skills to better manage risks and ensure the successful development and deployment of these advanced medical solutions.
    • Welcome and Opening Remarks from Workshop Chair

      • Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    • Overview and Introduction

      • Presenter: Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant

      • Presenter: Arun Mathew, EMBA, Associate Director, AbbVie

    • Practical Application of Risk Management Part 1: Intraocular Injections

      • Presenter: Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant

    • Practical Application of Risk Management Part 2: On-Body Injectors

      • Presenter: Arun Mathew, EMBA, Associate Director, AbbVie

    • Report Out and Discussion

  • Networking Break in the Exhibit Area

  • P2: Building a Strong Foundation: Defining Comprehensive Product Requirements

    • Moderator: Flora Felsovalyi, PhD, Associate Director, Lonza

    Join us for an engaging session on how to build robust sets of requirements with only limited information to begin with. We'll explore the essentials, starting points, and tools you need before formally starting development, along with considerations and sources for establishing requirements.

    We will then explore how to develop design inputs and specifications, including Essential Performance Requirements (EPRs), through practical case studies. Learn how to create precise requirements for scenarios like intraocular and on-body injections. These actionable strategies and valuable insights will enhance your approach to product development.
    • Case Study on Developing Inputs and Specifications Part 1: Intraocular Injections

    • Case Study on Developing Inputs and Specifications Part 2: On-Body Injections

      • Presenter: Matthew J. Huddleston, MS, Chief Commercial Officer, Enable Injections

    • Report Out and Discussion

  • Networking Lunch in the Exhibit Area

  • P3: Technical Considerations for Health Authority Submissions

    • Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical

    Combination products, with their unique blend of drugs, devices, and/or biologics, present distinct challenges in the regulatory arena. Understanding the intricacies of these products is crucial for ensuring compliance and expediting approval. In this interactive session, seasoned experts delve into the complexities of combination products and share invaluable insights into navigating the regulatory landscape and providing a comprehensive submission to health authorities.
    • Overview and Introduction

    • Defining Expectations and Best Practices Part 1: Intraocular Injections

      • Presenter: Fran DeGrazio, President & Principal Consultant, Strategic Parenteral Solutions LLC

    • Defining Expectations and Best Practices Part 2: On-Body Injections

      • Presenter: Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

    • Report Out and Discussion

  • Networking Break in the Exhibit Area

  • P4: Mastering Tech Transfer and Product Launch Readiness

    • Moderator: Flora Felsovalyi, PhD, Associate Director, Lonza

    In this dynamic session, industry leaders share their expertise and practical guidance on navigating the complexities of tech transfer and preparing for a successful product launch. From establishing robust transfer protocols and optimizing manufacturing processes to ensuring regulatory compliance, participants will gain insights into every facet of the tech transfer and launch readiness journey.
  • Networking Reception in the Exhibit Area

Friday, 25 October MDT

  • Continental Breakfast

  • Registration Open

  • P5: Impact of Post-Market Changes to the Medical Device and Best Practices for Submitting Variations in the European Market

    • Moderator: Akshay R. Kamdar, PhD, Senior Director, Eli Lilly and Company

    This session focuses on the intricacies of post-market changes for combination products marketed in Europe with real-world case studies. Attendees will work together in a small group interaction to define appropriate strategies and plans for successful submission in the European market. This hands-on approach provides valuable insights and practical experience, helping participants gain skills in managing post-market changes and navigate the complex regulatory landscape.
  • Networking Break in the Exhibit Area

  • P6: Navigating the Future: Unveiling Emerging Trends

    • Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    Explore the future trajectory of our industry through new and emerging trends. Our panel of experts will engage in a thought-provoking discussion, sharing insights and perspectives shaping our industry's landscape. This diverse exploration will provide you with a comprehensive understanding of the emerging forces driving innovation and change. We invite active participation from the audience, encourage feedback on the trends and welcome contributions on additional insights. This interactive exchange ensures that we collectively create a holistic view of the evolving dynamics within our industry. Don't miss this opportunity to gain valuable insights, engage in meaningful discussions, and contribute to shaping the future of our industry.
    • Unlocking Opportunities Through PDA Activities

      • Presenter: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    • Exploring Key Trends with Expert Insights

    • Interactive Discussion

    • Closing Remarks from Workshop Chair

      • Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

Agenda is subject to change.

Presenters

  • Maggie Bandel, MBA

    Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    Chair
    Moderator
    Presenter
    Read Bio
  • Edwin Bills, MEd

    Principal Consultant, Edwin Bills Consultant

    Presenter
    Read Bio
  • Bettine Boltres, PhD

    Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

    Presenter
    Read Bio
  • Fran DeGrazio

    President & Principal Consultant, Strategic Parenteral Solutions LLC

    Presenter
    Read Bio
  • Flora Felsovalyi, PhD

    Associate Director, Lonza

    Committee Member
    Moderator
    Read Bio
  • Matthew J. Huddleston, MS

    Chief Commercial Officer, Enable Injections

    Presenter
    Read Bio
  • Akshay R. Kamdar, PhD

    Senior Director, Eli Lilly and Company

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Lee Leichter, RAC, MBA

    President, P/L Biomedical

    Committee Member
    Moderator
    Read Bio
  • Arun Mathew, EMBA

    Associate Director, AbbVie

    Presenter
    Read Bio
  • Katie O'Neil

    Presenter
  • Anurag Patel, PhD

    Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.

    Presenter
  • Mahendran Ravichandran

    Director (Assoc.) R&D Combination Product Development, AbbVie (INVITED)

    Presenter
  • Subhi Saadeh

    Sr. Manager, Quality, Gilead Sciences

    Presenter
  • Geoffrey Wise

    Medical Device Platform Lead, Genentech

    Presenter

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Phoenix Convention Center - South Building

33 S 3rd Street
Phoenix, AZ 85004, United States
In Greater Phoenix, innovation is a way of life. Since ancient times, the Sonoran Desert has evoked inspiration, adaptation, collaboration, and innovation. This spirit is an indelible part of the identity and it inspires the approach to agriculture, technology, sustainability, hospitality, education, medicine, business, and so many other aspects that continue to shape Phoenix's future.

The result? Business is booming in the nation’s fifth-largest city. Technological and software companies are putting down roots at a rapid pace. Leading minds in energy, medicine, transportation, and other industries see Phoenix as a landscape for turning cutting-edge ideas into tools and products that the world benefits from!

Additional Hotel Information

Renaissance Phoenix Downtown (HQ)
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
Westin Downtown Phoenix
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
Residence Inn Phoenix Downtown
  • Rate: $279 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
Courtyard Phoenix Downtown
  • Rate: $269 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.

How to Get Here
By Air The closest airport to the Phoenix Convention Center - South Building is the Phoenix Sky Harbor International Airport (PHX - approx. 4 miles/6 km).
By Car The Phoenix Convention Center - South Building is located at 33 S 3rd Street, Phoenix, AZ 85004.