2012 PDA FDA Joint Regulatory Conference

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FDA

Compliance through Quality Systems: Implementing & Advancing a Sustainable Global Quality Culture
September 10-12, 2012 | Baltimore Marriott Waterfront Hotel | Baltimore, Maryland
Exhibition: September 10-11 | Post- Conference Workshop: September 12-13 | Courses: September 13-14

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Program Highlights

“The 2011 PDA/FDA Joint Conference was excellent. I was impressed by the large number of participants which expanded my networking opportunities.” Lynn Collins, BD

“Cross-cutting topics such as combination products, global supply chain and emerging markets are just a few of the pulse areas for today’s industry, where the collaboration of the PDA and FDA are vital in providing a forum for exchange. This conference truly provides something for everyone, regardless of your capacity in the industry.” Winston Brown, Baxter Healthcare

“It was great to listen and be able to meet and talk with the FDA speaker. I am back to France with a lot to share with my company.” Brigette Gayet, Guerbet

Important Deadlines – Register before June 29, 2012 - the first registration savings deadline | Hotel Cut Off: August 10, 2012

The 2012 PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.

Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance.

In the recent past there have been several recalls and increasing concerns about pharmaceutical glass packaging, both with regard to defects and/or incompatibilities with finished product over the shelf life. Pharmaceutical manufacturers, regulators, and glass suppliers all share a common goal of assuring the highest quality products (including packaging) for patients. This meeting will discuss these issues; best practice to preventing and/or detecting at risk glass packaging; and review current expectations to ensure that recalls are avoided and container closure integrity is assured.

Learning Objectives

  • Discuss Future Issues Impacting Pharmaceutical Manufacturing
  • Examine Case Studies from a Firm Making Dramatic Changes from Compliance Problems
  • Explain Quality System Structures to Incorporate CMC Aspects in Addition to CGMPs
  • Discuss Considerations for Development of Biosimilar Protein Products
  • Describe Effective Tech Transfer Approaches During the Product Lifecycle
  • Demonstrate Good Decision-making Through Risk Management
  • Identify Good Submission Practices in Type- C Submission
  • Summarize Quality Requirements and Challenges of Cell Therapy Development & Production
  • Discuss Quality & Compliance Culture in Merging Companies
  • Discuss FDA Interaction with Regulatory Counterparts
  • Identify CMO Challenges
  • Examine the Effectiveness of Virtual Companies
  • Discuss Drug Safety Issues
  • Summarize API Starting Material Expectations
  • Describe Integrity Knowledge Management
  • Summarize Root Cause Analysis for Recalls
  • Discuss the Accepted Guidance of GMPs for Excipients provided by IPEC
  • Discuss Issues with Selection of Excipients in Assessments of Submissions of New Drug Approvals
  • Provide Update on Hot Topics in Compliance Area
  • Summarize Current and Future Center Initiatives

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Contact

Conference inquiries:
Wanda Neal, CMP, Senior Vice President, Programs and Registration Services 
Tel: +1 (301) 656-5900 ext. 111
E-mail: neal@pda.org

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

Exhibition and sponsorship inquiries:
David Hall, Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Cell: +1 (240) 688-4405
E-mail: hall@pda.org

  Before June 29, 2012 June 29 - August 10, 2012 After August 10, 2012
Member $1,500 $1,700 $1,900
Nonmember $1,749 $1,949 $2,149
Government/Health Authority Member $ 530 $ 530 $ 530
Government/Health Authority Nonmember* $ 700 $ 700 $ 700
Academic Member $ 700 $ 700 $ 700
Academic Nonmember* $ 800 $ 800 $ 800
Student Member $ 280 $ 280 $ 280
Student Nonmember* $ 310 $ 310 $ 310
Post-Conference Workshop - Workshop Only $ 1,395
Post - Conference Workshop - Workshop and Full Conference Purchase
$ 1,245

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.


Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th 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 Patresa Day at day@pda.org for help.

2012 PDA/FDA Joint Regulatory Conference

Baltimore Marriott Waterfront Hotel 
700 Aliceanna Street
Baltimore, MD 21202
Phone: +1 (410) 385-3000
Website: www.marriott.com

Rate: Single: $229.00, plus applicable state and local taxes.

Cut Off Date: Friday, August 10, 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 2012 PDA/FDA Joint Regulatory Conference at the Baltimore Marriott Waterfront Hotel.  A block of rooms have been reserved at the group rate of $229 single or double occupancy, plus applicable state and local taxes. Reservations must be secured by Friday, August 10, 2012, after this date, reservations can be made on a space and rate available basis only.
To make reservations at the Baltimore Marriott Waterfront Hotel, please call the Hotel at +1 (410) 385-3000 and reference the 2012 PDA/FDA Joint Regulatory Conference 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 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Baltimore Marriott Waterfront Hotel is located in the heart of downtown Baltimore.  Local attractions include the Inner Harbor, Fort McHenry, the National Aquarium, the Baltimore Zoo, and Oriole Park at Camden Yards. All 773 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports
Baltimore/Washington International Thurgood Marshall Airport (BWI) 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: Ronald Reagan Washington National, 45 miles away and Dulles International, 52 miles away.

Ground Transportation
These airports do not provide shuttle service to the Baltimore Marriott Waterfront Hotel.  Taxi fares from BWI are approximately $30 one way, not including tip, and will take about 20 minutes. One way taxi fares from Reagan National is approximately $110 and from Dulles is about $150. 

Driving
Baltimore Marriott Waterfront Hotel is located on Aliceanna Street, off of President Street.

Parking at the Hotel

$8 / Hour Self Parking
$26 / Daily Self Parking
$40 / Daily Valet Parking

The 2012 PDA/FDA Joint Regulatory Conference will provide your company the premier opportunity to gain access to key decision makers and professionals who are shaping global regulatory strategies within the pharmaceutical and biotech manufacturing industry. Find new customers and strengthen current relationships by exhibiting at and/or sponsoring the industry’s leading conference and exhibition designed for regulatory and compliance professionals.

This year’s conference will provide ample opportunity for exhibitors to have face-to-face dialogue and direct information exchange with industry professionals who share a common goal of assuring the highest quality products for patients.  Company representatives will be on hand from manufacturing, quality, research & development, regulatory affairs, engineering, compliance, executive management, supply chain, clinical supplies, validation, and risk management.

Become a sponsor and/or exhibit at the 2012 PDA/FDA Joint Regulatory Conference and strengthen your brand image, increase your visibility, and gain access to leaders and subject matter experts in the pharmaceutical and biotech manufacturing 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

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