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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Combination Products Interest Group Meeting

May 11 - May 11, 2017 |
May 11, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Interest Group
  • Conference
  • Western Hemisphere Events
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A one-day meeting on combination products will be held in Bethesda, MD on May 11, 2017. This is designed to be an expansion of the usual 1.5 hour meetings held as part of the PDA Annual Meeting and/or PDA/FDA Joint Regulatory Conference. This format has been used in Europe with great success and offers the opportunity for extended discussion on hot topics regarding Combination Products. Our current plans are to identify not more than four main topics for discussion (two each for the morning and afternoon). We will provide a short overview of each topic and frame issues which are of interest and concern. We will then have an expert facilitate discussions and develop possible approaches or solutions to these challenging issues. In the spirit of Interest Group meetings, we hope to energize current and future Interest Group members to share their experience, thoughts and expertise and maximize attendee involvement.

Learning Objectives

At the completion of this event, attendees will be able to:

  • Identify and prospectively address key challenges in the development, approval and manufacture of combination products
  • Benchmark their own organization against others in the area
  • Explain unique issues and challenges in the development, approval and manufacture of combination products to peers and management
  • Propose potential approaches or solutions to these issues within their organizations

Who Should Attend

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

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

Contact

Jason Brown
Assistant Director, Programs 
Tel: (301) 656-5900 ext. 131
Email: brown@pda.org

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1 (240) 688-4405
Email: hall@pda.org

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Thursday, May 11, 2017

7:30 a.m. - 8:30 a.m.
Continental Breakfast

7:30 a.m. - 10:45 a.m.
Registration Open

8:30 am. - 10:00 a.m.
P1 - Combination Product Quality Systems
Moderator: Lee Leichter
, President, P/L Biomedical and Combination Products Interest Group Leader

Session Description: This session will focus on GMPs for Combination products, highlighting changes in the final guidance and the challenges and importance of implementing Risk management as part of your design controls and product lifecycle management.

Finalized guidance on GMPs
John Weiner,
Associate Director, Office of Combination Products, FDA

10:00 a.m. - 10:45 a.m.
Refreshment Break

10:45 a.m. - 12:15 p.m.
P2 - Regulatory Expectations for Combination Products
Moderator: Suzette Roan,
Associate Director, Regulatory Affairs, Biogen

Session Description: This session will focus on the regulatory expectations to gain approval to market combination products. Through presentations and interactive discussion, attendees will gain further understanding regarding expectations for human factors studies, common issues seen in submissions and recommendations for more streamlined reviews.

Regulatory Challenges with Submissions
John McMichael,
Biomedical Engineer, CDRH, FDA

Panelist:
Alan Stevens,
Branch Chief, General Hospital Devices, CDRH, FDA

12:15 p.m. –1:30 p.m.        
Lunch

1:30 p.m. - 3:00 p.m.
P3 - Connected Health
Moderator: Anthony Watson
, Associate Vice President, Regulatory Affairs, Devices, Sanofi US

Session Description: This will be a lively session discussing challenges from regulatory and development sides, regarding the digital health revolution. Participants from both the FDA and industry will discuss and provided perspectives on this very relevant topic.

The Medication Adherence Claim - Issues to Consider for Features of Devices, Combination Products, or Container closures that Create a Digital Record of Medication Usage
Rick Chapman,
Senior Director, Regulatory Affairs, Biogen

Clinical Study Regulatory Considerations for Software Products used in tandem with Drugs
Chin-Wei Soo,
Senior Regulatory Program Director, Genentech, inc., A Member of the Roche Group

Panelists:

Ashley Boam, Director, Office of Policy for Pharmaceutical, CDER, FDA
Michael Meissner, Vice President, Med Tech & Chief Technology Officer, Device Development, Sanofi-Aventis
Alan Stevens, Branch Chief, General Hospital Devices, FDA

3:00 p.m. – 3:45 p.m.
Refreshment Break

3:45 p.m. - 5:15 p.m.
P4 - Post-Approval Considerations
Moderator: Khaudeja Bano, MD,
Senior Medical Director, Medical Device Safety Head, AbbVie Inc.

Session Description: This session is formatted as an informal exchange/dialogue related to post-market safety reporting of adverse events for combination products, exploring the world of combination product safety. Participants will discuss the Post-market Safety Reporting (PMSR) final rule to help the audience appreciate the challenges of implementing PMSR in a global organization. In addition, this session will include:
• A FDA representative sharing key PMSR related information to help industry understand the basic requirements of the final rule.
• An interactive exercise featuring a hypothetical case of combination products approved as a drug/biologic application type with a device constituent part.
• Discussion about key challenges and solutions
• Handling of post market changes and risk management
• Actionable best practices and approaches

Adverse Event Safety Reporting Rule
John Weiner,
Associate Director, Office of Combination Products, FDA

Change Control/Risk Management
Chelsea O'Connell,
Regulatory Affairs Manager, Amgen, Inc.

Panelist:
Ashley Boam,
Director, Office of Policy for Pharmaceutical, CDER, FDA

Meeting Registration | May 11, 2017

Member

Before Mar. 17, 2017
$650

After Mar. 17, 2017
$850

Non-member

Before Mar. 17, 2017
$850

After Mar. 17, 2017
$1,050


Government/Health Authority/Academic

Member

Before Mar. 17, 2017
$300

After Mar. 17, 2017
$300

Non-member*

Before Mar. 17, 2017
$300

After Mar. 17, 2017
$300


Student

Member

Before Mar. 17, 2017
$280

After Mar. 17, 2017
$280

Non-member*

Before Mar. 17, 2017
$280

After Mar. 17, 2017
$280


All prices in US dollars.

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

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 Conference.

Multiple Meeting Discount

Receive a 10% off discount when you register for both the Pre-filled Syringe Interest Group Meeting (May 10) and the Combination Products Interest Group Meeting (May 11)!**

**Discount does not apply to Government/Health Authority/Academic rates

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. Please contact us at registration@pda.org 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 cancellation notice is not received by March 13, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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). If your written request in received on or before March 13, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site 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 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 info@pda.org 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. Recordings are prohibited at all PDA Conferences.

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 U.S.A

From Ronald Reagan National Airport (DCA)

Take George Washington Memorial Parkway to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Metro option: Please refer to the "Public Transportation" section for details.


From Washington Dulles International Airport (IAD)

Take VA-267 E/Dulles Access Toll Road to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From Baltimore Washington International (BWI) Thurgood Marshall Airport and Points North

Take I-95 South to I-495 West (toward College Park/Silver Spring).
From I-495 West, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From the South

Take I-95 North to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.


Parking

Parking is available in the parking garage below Bethesda Towers for $12 a day. PDA does not validate parking. There are also public lots within walking distance of the facility.

Public Transportation

PDA is located on the red line at the Bethesda Metro station. Once on the street level, proceed two blocks east on East West Highway to 4350 Bethesda Towers. PDA TRI is located on the first floor.

PDA is accessible from all three airports in the area either by Metrorail, Metrobus, or both. Please see the Metro map below for details.

Metro System Map

The following hotels are conveniently located near PDA:

Hilton Garden Inn

7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
+1 (301) 654-8111

Special Hotel Rate: $192 (plus applicable taxes)

Please use the code N0033113 when making your reservation to receive the rate listed above (rates are subject to availability).


Hyatt Regency Bethesda

One Bethesda Metro Center | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 657-1234 / +1 (800) 233-1234 (US Only)

Special Hotel Rate: $189 (plus applicable taxes) | January-February, July-August, November-December

Special Hotel Rate: $225 (plus applicable taxes) | March-June, September-October

Please use the code 78056 when making your reservation to receive the rates listed above (rates are subject to availability).


Residence Inn Marriott Bethesda Downtown

7335 Wisconsin Avenue | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 718-0200

No special rates available.


DoubleTree by Hilton Hotel Bethesda

8120 Wisconsin Avenue | Bethesda, MD 20814 | 0.8 miles from PDA
+1 (301) 652-2000

No special rates available.


Hilton Rockville Hotel & Executive Meeting Center

1750 Rockville Pike | Rockville, MD 20852 | 7.0 miles from PDA
+1 (301) 468-1100

Special Hotel Rate: $169 (plus applicable taxes)

Please use the code N2703011 when making your reservation via phone. Rates are subject to availability.

There will be high profile, cost-effective sponsorship opportunities available to a very limited number of companies. To secure your sponsorship, please contact David Hall, hall@pda.org, Tel: +1 (240) 688-4405.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3657

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