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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Combination Products Workshop

Oct 10 - Oct 10, 2018 |
Oct 10, 2018 |
Loews Royal Pacific | Orlando, FL
  • Workshop
  • Western Hemisphere Events
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Speaker Biographies

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

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


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

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

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

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.

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

Conference and Workshop Registration | October 8-10


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

Workshop Registration | October 10





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 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 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.

Loews Royal Pacific

Loews Royal Pacific
6300 Hollywood Way
Orlando, FL USA 32819
Tel: +1 (407)-503-3000

Rate: Single/Double: $205/per night, plus applicable taxes.

Cut Off Date: Thursday, September 6, 2018

(The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate). After the cut-off date, rooms will be available at the prevailing rate based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Loews Royal Pacific. The rate is $205 for single or double occupancy. Please note that over 90% of the Royal Pacific guestrooms are double queen rooms. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Thursday, September 6, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

To make reservations, individuals may click on the reservation link above or call the Loews Royal Pacific at +1 (888)-430-4999. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA conference to receive the PDA group rate.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 72 hours prior to check-in to avoid cancellation fees.


Loews Royal Pacific is conveniently located near Universal Orlando™. The venue is a tropical paradise with an unbeatable location right at the epicenter of fun. In addition to enjoying the lagoon-style pool and its own beach. As a guest, PDA attendees get exclusive benefits and access to the theme parks. Each and every one of the 1,000 stylish guest rooms is decorated in an "island chic" style that's as contemporary as it is laidback. The venue also offers a complimentary water taxi to the Universal CityWalk™ area, allowing guest to enjoy a variety of great restaurants and attractions.

Read more about additional information on service and amenities offered at Loews Royal Pacific.


Orlando International Airport- (MCO) is located 18 miles (about 20-25 minutes) northeast from Loews Royal Pacific.

Ground Transportation

Preferred Vendor

Destination MCO has been selected as the preferred vendor for airport transportation for Loews Hotels at Universal Orlando™. Exclusive chauffeured services begin at $115 (tax and gratuity included) for a sedan and can be charged to your geust room. Reservations are required. Visit or call the concierge at +1 (407)-503-5200.

Shared-Ride and Direct Service Airport Shuttles - Special Discount for PDA Attendees

Mears Transportation offers a shared-ride airport shuttle from Orlando International Airport to Loews Sapphire Falls. Tickets are available at the Mears Transportation counters located inside the baggage claim area on level two, as well as on level one where the shuttle departs for Loews Sapphire Falls Resort every 30 – 40 minutes. Reservations are not required. Pricing is shown below.

  • One-way fare: $21 adult or $16 child (ages 3-9)
  • Round-trip fare: $33 adult or $25 child (ages 3-9)

Mears Transportation also offers a direct service airport shuttle from Loews Royal Pacific to Orlando International Airport. Travel time is approximately one hour. Reservations are required. Visit or call the concierge at 407.503.5200 at least 24 hours prior to departure.


Taxis are on standby at Orlando International Airport, offering service to and from Loews Royal Pacific for an approximate fare of $55 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 30 minutes.


From Orlando International Airport
Take the north exit onto the Beachline Expressway (State Road 528) West approximately 11 miles to Interstate 4 (I-4) East. Continue on I-4 East to exit 75A (Universal) and turn left onto Universal Boulevard. Continue on Universal Boulevard to Hollywood Way and turn left. Loews Royal Pacific is on the left at 6300 Hollywood Way.
Note: FL-528 is a toll road with two tolls of $0.75 and $1.00 each between Orlando International Airport and Loews Royal Pacific.

From Florida's Turnpike
Take exit 259 (Orlando) onto I-4 West. Travel on I-4 West to exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the second entrance on the right.

From Eastbound Interstate 4
Take exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

From Westbound Interstate 4
Take exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the second entrance on the right.

From Southbound Interstate 95
Take exit 205 (State Road 528). Travel on FL-528 to I-4 East. Travel on I-4 East to exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

From Northbound Interstate 95
Take exit 260B (I-4 West). Travel on I-4 West to exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

Hotel Parking

Self-parking at the Loews Royal Pacific is $22 overnight or $24 daily. Valet parking is $29 overnight or $34 daily.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Combination Products Workshopwill provide your company the premier opportunity to network with key decision makers in this dynamic field. Find new customers and strengthen current relationships by exhibiting at and/or sponsoring this Workshop.

The Workshop agenda will provide ample opportunity for exhibitors to have face-to-face dialogue and direct information exchange with industry professionals who are involved in development, approval and manufacturing of drug delivery combination products. Attendees will include industry professionals from compliance, CMC, packaging, operations, quality, regulatory affairs, supply chain, procurement, and other technical functions.

Become a sponsor and/or exhibit at the 2018 PDA Drug Delivery Combination Products Workshop to strengthen your brand image, increase your visibility, and gain access to leaders and subject matter experts in the biopharmaceutical industry. For more information, contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296

Register Now