Join more than 700 generic industry professionals and attend this unique educational conference where FDA and industry experts share experiences and knowledge about drug product research and development and ANDA application review. Hear presentations from key industry leaders, industry scientists, and agency officials on topics ranging from compliance and inspections to the impact and expectations of GDUFA II commitments for ANDA review timelines and first cycle approvals and much more.
Key Conference Objectives
- State of FDA Keynote Address by the Commissioner
- State of OGD Address
- State of OPQ Address
- State of ORA Address
- Data Integrity Issues in Today's Complex and Global Manufacturing Supply Chain
- Anatomy of an Expedited/Priority Review
- GDUFA II Pre-ANDA Program for Complex Products
- Rising Drug Costs - The Impact of Generics
- Bioequivalence Issues and Concerns
- OGD Update: GDUFA II Review Program Enhancements - What Industry Needs to Know
- Expo Interactive Session
- International Harmonization - International Generic and Biosimilar Medicines Association (IGPBA) Perspective
- And much more.
Pre-Conference USP Workshop - November 6
U.S. Pharmacopeia (USP) will host the USP Workshop on November 6th. All conference attendees are invited to join USP for an interactive discussion of timely issues and USP initiatives relevant to the generic pharmaceutical industry. USP representatives will provide updates on the latest USP services available such as publications, Reference Standards, and opportunities for involvement. Space is limited. Early registration is recommended.
Exposition (Interactive Session) - November 7
Back by popular demand, AAM will present a session titled "Expo" which will feature industry and FDA booths that will allow for one-on-one interactions between industry and FDA on select topics on the afternoon of November 7th. Industry experts will share strategies for how to successfully develop drug products and best practices for managing GDUFA timelines. Don't miss out on this great opportunity to learn and share ideas with fellow industry colleagues and FDA.
AAM will host a variety of exciting professional networking opportunities which include a welcome reception, two breakfasts, luncheons, morning and afternoon refreshment breaks, and the very first AAM Lip Sync Battle at the dinner and entertainment on Tuesday, November 7. We highly encourage conference participants to build their own teams to battle others with their epic performances!
Fall Technical Conference Registration: November 6-8, 2017
AAM Members (per representative) $2,750.00
Non-Members (per representative) $3,125.00
Government (per representative) $700.00
Cancellations must be received in writing either faxed to 202-249-7105 or emailed to firstname.lastname@example.org by Monday, October 16, 2017, and confirmed by AAM. All cancellations are subject to a $300 processing fee. No refunds after October 16, 2017.
Showcase your organization’s products and services by participating in this prestigious event. AAM has many sponsorship levels including Host, Premier Platinum, Premier, Breakfast, Luncheon, Amenity, Lanyard, Mobile App, Room Key, Wireless Internet, Networking Break, Welcome Reception, and Supporting sponsorship for 2017. Each includes significant exposure to our meeting attendees throughout the program. Booth space included in the Premier Platinum and Premier Sponsorships are limited. Reserve your space today! For more information contact Jennifer Soup at email@example.com.
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road North
Bethesda, MD 20852
Reservations must be made directly with the Bethesda North Marriott Hotel and Conference Center by calling 877-212-5752. Please refer to the meeting name: “AAM Fall Technical Conference” to obtain the preferred rate. Only a limited number of preferred rate rooms are available. The preferred rate cutoff date is October 16, 2017. After this date or after the preferred rate rooms are sold out rooms are subject to hotel rates and availability.
The Conference Center parking lot is under construction as it is in the process of being converted into a parking garage. Overnight hotel guests will still be able to park in the hotel parking lot. Those of you NOT staying overnight at the hotel will need to park in the secured garage at 6130 Executive Blvd Rockville, MD 20852 (just a few blocks from the conference center, approximately 4 minute drive). Please add an extra 15 minutes to your commute to the Conference Center to ensure you will not be late for the meeting. The conference center will provide shuttles to and from the garage which will run continuously. Parking for all AAM Fall Technical Conference Workshop attendees is complimentary.
Directions to Offsite Parking Garage
From 5701 Marinelli Rd, North Bethesda, MD 20852
Turn Right onto Marinelli Rd.
Turn Right at the light onto Executive Blvd
Turn Left at the 3rd light
Continue straight to the parking garage
Parking Garage Address: 6130 Executive Blvd, Rockville, MD 20852