PDA Combination Products Workshop 2024

Breaking Boundaries: Faster, Better, Smarter

24 Oct - 25 Oct 2024
Phoenix, AZ

Become a Sponsor and/or Exhibitor

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

Program Planning Committee

The Team Behind the Event's Agenda

Promotions and Press

Request Press Pass
Submit Your Information

Location and Travel

Venue Details and Accommodations

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

Registration

Pricing Options

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.

Presenters

Meet the Experts
  • Maggie Bandel, MBA

    Maggie Bandel, MBA

    Johnson & Johnson

    Global Head Lifecycle Management ATSC MSAT

    Chair
    Moderator
    Presenter
    Read Bio
  • Edwin Bills, MEd

    Edwin Bills, MEd

    Edwin Bills Consultant

    Principal Consultant

    Presenter
    Read Bio
  • Bettine Boltres, PhD

    Bettine Boltres, PhD

    West Pharmaceutical Services

    Director Scientific Affairs & Technical Solutions, Integrated Systems

    Presenter
    Read Bio
  • Fran DeGrazio

    Fran DeGrazio

    Strategic Parenteral Solutions LLC

    President & Principal Consultant

    Presenter
    Read Bio
  • Flora Felsovalyi, PhD

    Flora Felsovalyi, PhD

    Lonza

    Associate Director

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

    Matthew J. Huddleston, MS

    Enable Injections

    Chief Commercial Officer

    Presenter
    Read Bio
  • Akshay R. Kamdar, PhD

    Akshay R. Kamdar, PhD

    Eli Lilly and Company

    Senior Director

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

    Lee Leichter, RAC, MBA

    P/L Biomedical

    President

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Arun Mathew, EMBA

    Arun Mathew, EMBA

    AbbVie

    Associate Director

    Presenter
    Read Bio
  • Katelyn O'Neil

    Pfizer

    Senior Manager, Device Engineering

    Presenter
  • Anurag Patel, PhD

    Anurag Patel, PhD

    Merck & Co., Inc.

    Director, Regulatory Affairs-CMC Device and Drug-Device Combinations

    Presenter
    Read Bio
  • Geoffrey Wise

    Geoffrey Wise

    Genentech

    Medical Device Platform Lead

    Presenter
    Read Bio

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

Exhibitors

Exhibitors and Innovators
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Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become a Sponsor and/or Exhibitor

Amplify Your Presence and Reach Your Customers!
Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Combination Products Workshop 2024! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

Request Information
Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the PDA Combination Products Workshop 2024! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

Request Information
Contact Us
Have a question or need assistance?

Send us a message, and our team will get back to you shortly. We're here to help!

Contact

Program Inquiries
Brooke Lustig, CMP
Tel: +1 (301) 656-5900

Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405

Training Course Inquiries
Tel: +1 (301) 656-5900

Registration Customer Care
Tel: +1 (301) 656-5900