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2018 PDA Combination Products Workshop

Oct 10, 2018
Orlando, FL

  • Workshop
  • The Americas

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Program Highlights

At the 2018 PDA Combination Products Workshop gain insight from pharmaceutical and medical device professionals on the development, regulatory approval process, and lifecycle management of drug delivery combination products and use that knowledge to ensure future success for your product and your company!

Overview

Listen to the real life experiences of guidance from experienced pharmaceutical and Medical Device professionals detailing the challenges they have, or are currently facing. Learn from their experiences and solutions they have implemented during development, approval and life-cycle management of their Drug Delivery Combination Products. Learn which activities succeeded and lessons learned. Interact with the participants in panel discussions on the issues that are important to the success of your product and company in the future.

Learning Objectives

At the completion of this workshop, attendees will:

  • Identify and prospectively address key challenges in the development, approval and manufacture of Drug Delivery Combination Products
  • Recognize potential liabilities and opportunities within their organization
  • Benchmark their own organization against others in the area
  • Explain unique issues and challenges in the development, approval and manufacture of Drug Delivery Combination Products to peers and management

Who Should Attend

Departments
Device Development | Compliance | Operations | Regulatory Affairs | Manufacturing | Pharmaceutical Formulation and Process Development | Business Development | Marketing | Procurement | CMC | Distribution | Packaging | Quality Assurance/Control| Clinical Affairs

Job Function
Manufacture of Parenteral Products | Packaging Scientists & Engineers | Stability Coordinators | Supply Chain | Logistics | Clinical Development | Business Development | Formulators | Device Development and Engineering | Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals

Contact

Workshop Inquiries
Jason E. Brown
Assistant Director, Programs
Tel: +1 (301) 656-5900 ext. 131, Email: [email protected]

Registration Customer Care:
Tel: +1 (301) 656-5900 ext. 115, Email: [email protected]

Exhibition inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160 Email: [email protected]

Agenda

  • Wednesday, October 10

    7:00 a.m. - 5:15 p.m.
    Registration Open

    7:15 a.m. - 8:15 a.m.
    Continental Breakfast

    8:15 a.m. - 8:30 a.m.
    Welcome and Opening Remarks from Committee Chair
    Lee Leichter, President, P/L Biomedical

    8:30 am. - 10:00 a.m.
    P1: Connected Health and Drug Companies
    Moderator: Richard (Rick) Chapman, Senior Director, Medical Device Software Factory, Sanofi

    There has been a proliferation of digital tools and devices, and connected combination products, brought forward by Drug and Biologics companies in the last decade, and it seems to be accelerating. These digital things are used in clinical trials, adjuncts to labeling and in advertising and promotional materials, and in prescription and consumer products. In this session, we’ll discuss a few of the many issues (e.g. cybersecurity, impact of differences in drug versus device laws and regulations, company internal cultural adaptations, systems of digital things) that Drug companies face in bringing these new technologies forward.

    8:30 a.m. - 9:00 a.m.
    The Digitization of Drug Delivery
    Paul Schultz, Head of Partnerships, Flex 

    9:00 a.m. - 9:30 a.m.
    How Digital Technologies Enhance Patient Engagement
    Eric Chanie, 
    Director, Healthcare Intelligence & Business Development, Merck Group

    9:30 a.m. - 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. - 3:45 p.m.
    Exhibit Area Open

    10:00 a.m. - 10:45 a.m.
    Refreshment Break in Exhibit Area

    10:45 a.m. - 12:15 p.m.
    Concurrent Sessions

    A1: New Technologies
    Moderator: Marc Rohrschneider, PhD, Head New Technologies, Novartis Pharma AG

    The session will provide an overview of the latest trends for combination products and the future challenges and hurdles the pharma pipelines provide for drug-device developments. In a world which has been strongly driven by new guidelines, regulations and therapies over the last few years, it is important to understand the future requirements and strategies for successful developments. We will discuss new technologies and regulatory options to transfer latest technology trends to clinic and market including insights into innovative delivery systems and their applications.

    10:45 a.m. - 11:15 a.m.
    Innovation Management for New Technology Delivery Systems: A Pharma Perspective
    Alexander Jung, PhD, Senior Innovation Manager – Drug Delivery & Devices, Boehringer Ingelheim Pharma GmbH & Co. KG

    11:15 a.m. - 11:45 a.m.
    New Technology Delivery Systems: A Regulatory Perspective
    Sarah Mollo, PhD, Biocompatibility Consultant and Lead Reviewer, General Hospital Devices, CDRH, FDA

    11:45 a.m. - 12:15 p.m.
    Questions and Answers/Discussion

    B1: Products Intended to be Used Together: A Marriage of Convenience or Necessity?
    Moderator: Anthony Watson, Associate Vice President, Regulatory Affairs, Devices, Sanofi

    The combination product arena has many players. One area that is often overlooked but has several important challenges is the case where two or more different types of products are intended to be used together but not physically combined as a single entity. These products can be placed into the same packaging or they can reference each other through labeling only. We hear terms like convenience kit, co-packaged combination product, cross-labelled combination product. Are these really different products? Are there any differences in requirements or is this a distinction without a difference? History plays a significant role here that can have an impact on product development and regulatory pathways. Attend this engaging session to hear from regulators and experts in the field with practical experience.

    10:45 a.m. - 11:15 a.m.
    General Delivery vs. Cross-Labeled
    Carolyn Cochenour Dorgan, MS, Acting Senior Lead Reviewer, General Hospital Devices Branch, CDRH, FDA

    11:15 a.m. - 11:45 a.m.
    Challenges of Establishing a Kit vs. Co-Packaged Combination Products
    Sugato De, Principal Consultant, PAREXEL International

    11:15 a.m. - 11:45 a.m.
    Questions and Answers/Discussion

    12:15 p.m. - 1:30 p.m.
    Lunch 

    1:30 p.m. - 3:00 p.m.
    Concurrent Sessions

    A2: Generic and Biosimilar Combination Products
    Moderator: Lee Leichter, President, P/L Biomedical

    More products with delivery systems that were approved years ago are now subject to competition through generic (505(j) ANDA) and biosimilar (351(k) BLA) submissions.  These present unique challenges in addition to those facing New Molecular Entity (NME) combination products.  Development of these products, including establishing their comparability to the Reference Drugs or Biologics require different development strategies and assessment tools.  In addition to validating that the drug entity is the same, Generic and Interchangeable Biosimilar products must establish that the delivery systems do not differ in any significant way, even though the products they are replacing may be old technology, not user friendly and may have never been subjected to the same requirements when they were approved.  These presentations and discussions will identify, explain and help with the understanding of these  the new approaches and expectations for these products.

    1:30 p.m. - 2:00 p.m.
    Combination Product Development for Biosimilars and Generics: The Devil is in the Detail
    Alastair Clarke, Managing Director, Weaver Technical Solutions LTD

    2:00 p.m. - 2:30 p.m.
    Human Factors for Generic and Biosimilars (Interchangeable)
    Christoph Jordi,
    Senior Usability Manager, Ypsomed AG

    2:30 p.m. - 3:00 p.m.
    Questions and Answers/Discussion

    B2: Post-Commercialization
    Moderator: Carolyn Cochenour Dorgan, MS, Acting Senior Lead Reviewer, General Hospital Devices Branch, CDRH, FDA

    Change is an inherent part of the total product life cycle of a combination product. Consideration and management of that change is one of the most critical aspects of a quality management system, yet for combination product manufacturers, it can be nebulous and challenging due to the lack of established processes or best practices. How do manufacturers decide when to handle the change internally, versus notifying the appropriate regulatory body?  How do you capture adverse events and where do you report them? How do you maintain a design history file that incorporates changes to the drug and device constituents of combination products?  This session will explore best practices to the challenges facing combination product manufacturers including change management, adverse event report and knowledge management throughout the total product life cycle.

    1:30 p.m. - 2:00 p.m.
    ISO 20069: Assessment & Evaluation of Changes to Drug Delivery Systems  
    Paul Jansen, PE, Board Member & Senior Advisor, Haselmeier

    2:00 p.m. - 2:30 p.m.
    The Landscape of Post Market Surveillance (PMS)
    Dana Fashina, Software Quality Manager, Sanofi-MED

    2:30 p.m. - 3:00 p.m.
    Questions and Answers/Discussion

    3:00 p.m. - 3:45 p.m.
    Refreshment Break in Exhibit Area

    3:45 p.m. - 5:15 p.m.
    P2: Challenges for Device Development in a Global Economy
    Moderator:  Olivia Henderson, PhD, Principal Engineer, Amgen, Inc.

    Device development requires large financial, technical, and human resource investments. In today’s global economy it is important to be able to reach all available markets to maximize the return on that investment. The expectations from the different global regulatory bodies may vary significantly, even when the intent is the same, namely to provide safe and effective medications for the represented population. This session will discuss a few of these different global regulatory expectations and strategies for overcoming the challenges.

    3:45 p.m. - 4:15 p.m.
    Impact of MDR on Combination Products: Role of Notified Bodies
    Girish Kumar, PhD,
    Product Specialist, TÜV SÜD America                                            

    4:15 p.m. - 4:45 p.m.
    Medical Device Regulation (MDR, Article 117): Impact on Pharma and Biotech Companies and Related Survival Strategies
    Beat U. Steffen, Founder & CEO, Confinis AG

    4:45 p.m. - 5:15 p.m.
    Questions and Answers/ Discussion

    5:15 p.m.
    Closing Remarks from Committee Chair
    Lee Leichter, President, P/L Biomedical


Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

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.

Loews Royal Pacific

6300 Hollywood Way
Orlando, FL

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Conference and Workshop Registration | October 8-10

Member

By July 30, 2018
$2,645

After July 30, 2018
$3,345

Non-member

By July 30, 2018
$2,924

After July 30, 2018
$3,624


Workshop Registration | October 10

Member

$800

Non-member

$800

All prices in US dollars.

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at [email protected] for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by August 9, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before August 9, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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