The Association for Accessible Medicines (AAM) is pleased to announce that its 2017 two-day CMC Workshop will be held on May 23rd and 24th in Bethesda, MD. This workshop will help you develop an in-depth understanding of various topics such as FDA’s current CMC expectations for ANDAs, the Office of Pharmaceutical Quality’s (OPQ) current thinking regarding facility assessments, and up-to-date expectations on the FDA’s quality standards as OPQ moves towards "One Quality Voice."
Attend this interactive workshop and gain the knowledge you need to best navigate current CMC regulatory quality requirements as well as witness unique in depth discussions among industry leaders and key officials from OPQ and the Office of Generic Drugs (OGD). Several of the discussions will take a deeper dive into some of the key topics discussed in prior CMC Workshops to provide further insight into how industry can better manage the GDUFA landscape.
Key Objectives
- OPQ’s Lifecycle Approaches
- Complex Drug Products
- First Cycle Approvals
- Drug Product Naming Conventions/Nomenclature and Compendial Requirements
- Elemental Impurities
- Quality Related Deficiencies and Clarity on Major Deficiencies
- ANDA Quality Recommendations and Expectations –The Entire Process
- Drug Master File Update
- Microbiology/Sterility Assurance
- Process and Facility – Implementing Integrated Process Facility Review
- Data Integrity – Quality Metrics and Quality Culture
- Program Management: Communicating with the Regulatory Business Process Managers (RBPM’s)
Meeting Registration
AAM Member: $1,775.00
Nonmember: $2,120.00
Cancellation Policy
Cancellations must be received in writing either faxed to 202-249-7105 or emailed to aagee@gphaonline.org by Monday, May 1, and confirmed by AAM. All cancellations are subject to a $300 processing fee. No refunds after May 1, 2017.
Sponsorship Opportunities
Raise your company profile by participating in this prestigious event. For more information, regarding sponsorship levels and benefits contact Jennifer Soup at Jennifer.Soup@accessiblemeds.org. AAM is offering sponsorship opportunities that include significant exposure to the workshop attendees throughout the program. For more information, contact Jennifer Soup at Jennifer.Soup@accessiblemeds.org.
CMC Workshop 2017 Sponsorship Form
Hotel Information
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 1-800-859-8003. Please refer to the meeting name: “AAM CMC Workshop” to obtain the preferred rate. Only a limited number of preferred rate rooms are available. The preferred rate cut off date is May 1, 2017. After this date or after the preferred rate rooms are sold out, rooms are subject to hotel rates and availability.
Parking
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 CMC 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
Conference Materials - Download AAM Meetings & Events App!
Download AAM Meetings & Events app by clicking here on your mobile device or by going to your iTunes app store for apple users / Play Store for android users. Once downloaded, log in and customize your experience. For more tips on how to customize your app experience, check out these step by step instructions for logging in. Conference materials (agenda, floor plan, speaker biographies, presentations, and etc) will be available via mobile app. Please make sure you download the mobile app in advance.
For questions regarding registration for the 2017 AAM CMC Workshop, please contact Aquera Agee at (202) 249-7138 or aquera.agee@accessiblemeds.org.