This workshop is intended to facilitate discussion of concepts captured in the A-Vax case study (public availability scheduled for early 2012) within the vaccine industry and with regulatory health authorities.  The focus of presentations will be the exploration of tools and frameworks to enable ICH Q8, Q9, and Q11 implementation strategies in vaccine development. 

Five vaccine manufacturers (GSK, MedImmune, Merck, Pfizer, and Sanofi Pasteur) formed a collaboration to prepare a case study to illustrate how Quality by Design (QbD) could be applied to vaccine development.  Facilitated by PwC, the intent of the initiative was to help stimulate discussion within Industry as well as between industry and the regulatory agencies to better understand the challenges associated with trying to apply QbD to vaccine development and in turn, understand how these challenges might be overcome. The case study is not intended to provide a “gold standard” in terms of how vaccines should be developed using QbD but instead, provide opportunities to discuss novel ideas that in the end might help improve the overall process for developing and manufacturing vaccines. 

PDA has partnered with the consortium to promote and disseminate the case study via public posting and to facilitate public discussion through this workshop.  The workshop marks a significant opportunity to expand these critical discussions on the implementation of QbD concepts in vaccine development within the vaccine community.

Contact

Conference inquiries:

Leon D. Lewis
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149
Email: lewis@pda.org

Registration inquiries:

Patresa Day
Manager, Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
Email: day@pda.org 

Exhibition/Sponsorship inquiries:

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Direct: +1 (240) 688-4405
Email: hall@pda.org

CMC Pre-Conference Workshop - Workshop Only	$ 650
CMC Pre-Conference Workshop - Workshop and Full Conference Purchase (PDA/FDA Virus and TSE Safety Conference)	$ 500

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.

Hyatt Regency Bethesda 
One Bethesda Metro Center (7400 Wisconsin Ave.)
Bethesda, MD 20814
Phone: +1 (301) 657-1234
Website: www.bethesda.hyatt.com

Online reservation: https://resweb.passkey.com/go/
Rate: Single: $225.00, plus applicable state and local taxes.

Cut Off Date: Monday, April 16, 2012 (Availability may be limited.  Requests will be processed on a first-come, first-served basis.  Attendees staying within the PDA block will receive the conference rate.) 

Hotel Accommodations

PDA is excited to host the Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop at the Hyatt Regency Bethesda.  A block of rooms have been reserved at the group rate of $225 single or double occupancy, plus applicable state and local taxes. Reservations must be secured by Monday, April 16, 2012, after this date, reservations can be made on a space and rate available basis only.
To make reservations at the Hyatt Regency Bethesda, please call the Hotel at +1 (301) 657-1234 and reference the Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

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 3 p.m. one day prior to arrival otherwise specified on your reservation information.

Amenities

Just one mile from the MD/DC line, Hyatt Regency Bethesda is perfectly-positioned to allow you to take advantage of all Washington DC has to offer. Located directly above the Bethesda Metro station (Red Line), you're walking distance to numerous area businesses and minutes from Maryland's best shopping, dining and cultural attractions. All 390 guest rooms and suites provide high-speed Internet, Hypo-Allergenic room purification, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 12 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 15 minutes. One way taxi fares from Dulles is approximately $65 and from BWI about $75. 

Driving
The Hyatt Regency Bethesda is located on Wisconsin Avenue.

Metro
The Hyatt Regency Bethesda is located on the RED line at the Bethesda Station.

Parking at the Hotel

$10 Self Parking (without In & Out Privileges)
$15 Self Parking (with In & Out Privileges)
$ 20 Valet Parking

 

The Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop will provide your company the premier opportunity to gain access to and network with key decision makers from the biopharmaceutical science and manufacturing industry. Find new customers, discuss ongoing projects, discover new opportunities, and reconnect with current clients by exhibiting at or sponsoring the industry’s leading conference and exhibition on vaccine development and manufacture. Extended, dedicated exhibit hall hours will allow ample time for information exchange with attendees and industry subject matter experts from manufacturing, quality assurance, process/product development, and regulatory affairs. Many high profile, cost-effective sponsorship options are available to help your company increase exposure, build awareness, and stand out from the crowd. Become a sponsor and/or exhibit at the Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop(CMC) Workshop and strengthen your brand image, increase your visibility, and gain access to hundreds of leaders in the industry.

For exhibition and sponsorship inquiries, please contact:

David Hall
Vice President, Sales
Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
E-mail: hall@pda.org