PDA Combination Products Workshop 2024

Breaking Boundaries: Faster, Better, Smarter

Phoenix, AZ
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Mastering the Combination Product Lifecycle from Development through Commercialization

Combination products, with their unique blend of drugs, devices, and/or biologics, present distinct challenges for teams and companies. Understanding the intricacies of the combination product lifecycle from development through commercialization is critical to ensure success.

PDA’s highly interactive Combination Products Workshop is designed and led by top industry experts and delivers the knowledge, practical application and best practices for navigating you and your team through the entire lifecycle of combination products from development through commercialization. The intent is to ensure retention and comprehension for immediate application of your learning.

During the workshop, you will have the opportunity to engage, explore and get your questions answered. A firmer grip on understanding the regulatory environment in relation to combination products is crucial for ensuring compliance and expediting approval.

Whether you are just starting out in the industry or an experienced professional, this workshop is for you.

Why Attend?

You will be equipped with essential knowledge and practical skills in risk management, verification and validation, developing comprehensive requirements, preparation for submission readiness, manufacturing and technology transfer best practices, and change management.

  • Real-World Application: Engage in interactive case studies drawn from actual industry scenarios.
  • Immediate Impact: Apply your newly acquired knowledge to your current projects right away.
  • Global Perspective: Gain insights into navigating diverse regulatory frameworks across regions including the European Union.
  • Networking Opportunities: Connect with peers and experts across the workshop to build a network of professionals.
  • After the workshop, join PDA’s Combination Products Interest Group, chaired by industry experts to ensure you stay up to date with regulatory changes and innovations across the combination products lifecycle.

The entire workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts.

What Will You Gain?
  1. Comprehensive Lifecycle Knowledge: Ability to navigate the entire journey from development to commercialization with confidence.
  2. Risk Management Expertise: Skills to identify, assess, and mitigate risks effectively specific to combination products.
  3. Validation and Verification: Assurance that your combination products meet the highest standards of quality and safety.
  4. Regulatory Navigation Skills: The confidence to conquer the complex landscape of global regulations.
  5. Manufacturing Excellence: Discovery of the best practices in production and technology transfer.
  6. Change Management Proficiency: The perspective to adapt to industry shifts with agility and foresight.
  7. Access to industry experts and PDA’s Combination Products Interest Group.
Who Should Attend?

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

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

Don't miss out! Limited spots available!

Secure your place now and take a transformative journey to combination product mastery from development to commercialization. Your career advancement awaits!

Register today and propel your expertise to new heights of success!

PROGRAM PLANNING COMMITTEE

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

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

$2,495

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 registration@pda.org.

Thursday, 24 October MDT

  • Continental Breakfast

  • Registration Open

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

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

    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

    • 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

  • Networking Break in the Exhibit Area

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

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

    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.
    • Overview and Introduction

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

    • Case Study on Developing Inputs and Specifications Part 1: Intraocular Injections

      • Presenter: Geoffrey Wise, Medical Device Platform Lead, Genentech

    • 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.
    • 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, Integrated Systems, West Pharmaceutical Services

    • Interactive Case Study

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

    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.
    • Overview and Introduction

      • Presenter: Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.

    • Developing Strategies for Successful EU Market Submissions: A Hands-On Exercise

      • Presenter: Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.

    • Report Out and Discussion

  • 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, Integrated 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
    Presenter
    Read Bio
  • Arun Mathew, EMBA

    Associate Director, AbbVie

    Presenter
    Read Bio
  • Katelyn O'Neil

    Senior Manager, Device Engineering, Pfizer

    Presenter
  • Anurag Patel, PhD

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

    Presenter
    Read Bio
  • Geoffrey Wise

    Medical Device Platform Lead, Genentech

    Presenter
    Read Bio

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
Make a Reservation
Westin Downtown Phoenix
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
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Residence Inn Phoenix Downtown
  • Rate: $279 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
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Courtyard Phoenix Downtown
  • Rate: $269 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
Make a Reservation

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.