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GADA/CVM Quarterly Meeting – October 23, 2014
Rockville, MD
Schedule of Events & Hotel/Meeting Information
Wednesday, October 22, 2014
Arrivals
Hotel
Sheraton Rockville Hotel
920 King Farm Boulevard, Rockville, MD 20850
Phone: (240) 912-8200
Reservation Deadline: October 8, 2014
See next page for room reservation information.
6:30 pm
Group Dinner
Offsite Restaurant – Location TBA
Members will share in the cost of this Group Dinner.
Thursday, October 23, 2014
6:00 am – 8:30 am
Breakfast
Complimentary breakfast for Sheraton guests
in the Sheraton’s King Farm Grill restaurant
8:30 am
Departure
Depart Sheraton Hotel for FDA Offices
Meet in lobby by 8:15 am for group departure.
9:00 am-12:00 noon
GADA-Generics Group
Meeting
FDA – CVM Offices
7500 Standish Place, Rockville, MD 20855
(AdobeConnect Virtual Participation available)
12:00 noon-1:00 pm
Lunch Break
Standish Café, Rockville, MD
1:00 pm – 3:00 pm
GADA-CMC Group
Meeting
7519 Standish Place, Rockville, MD 20855
(AdobeConnect Virtual Participation available)
2105 Laurel Bush Road, Suite 201, Bel Air, MD 21015-5200
Phone (443) 640-1046, ext. 119 Fax (443) 640-1043
Email: [email protected] www.gadaonline.org
GADA/CVM Quarterly Meeting – October 23, 2014
Rockville, MD
Schedule of Events & Hotel/Meeting Information
Registration
Whether attending in person or virtually, all attendees for the GADA-CVM Quarterly meeting must be
registered in advance. To gain access to the FDA facilities, all on-site attendees will be subject to security
screenings and will be required to produce a photo I.D. upon entering the FDA buildings. GADA needs to
know, for planning purposes, who will be attending as well as whether transportation can be shared among
attendees; we also need to know where to send instructions for virtual attendees, so pre-registration of all
attendees is important.
Please register online at https://www.surveymonkey.com/s/GADAoct2014 no later than October 8,
2014, or, you may call Kathy DeMarco at (443) 640-1046, ext. 119 to register by phone. There is no
registration fee; members pay for their own travel/hotel/meal expenses. Member organizations may send
multiple attendees to attend in person, as well as registering additional attendees to attend virtually.
Hotel Reservations
Hotel reservations are available at a special GADA rate of $149/night plus tax (single or double occupany)
for the evening of October 22 (plus up to three nights before and after, based on availability). To reserve,
call the Sheraton Rockville Hotel at (240) 912-8200 and ask for a reservation in the GADA ROOM BLOCK.
A credit card will be required to guarantee the reservation; the card will be charged for one night’s stay
unless reservation is more than 24 hours prior to arrival.
Guest rooms at the GADA rate are available on a first-come first-served basis; GADA cannot guarantee
availability of rooms, so be sure to make your reservation as soon as possible, but no later than
Wednesday, October 8, 2014.
As part of our GADA agreement with the Sheraton Rockville Hotel, the rate includes complimentary highspeed internet, and complimentary breakfast for GADA guests.
The Sheraton also provides a complimentary shuttle within a 5-mile radius (including the Shady Grove
Metro train station, which is approximately 1.5 miles from the Sheraton), and complimentary self-parking.
Meeting Agendas
The preliminary, unconfirmed agenda for the CVM Quarterly Meetings includes discussions with the
Generics Team on issues including Ivermectin and environmental assessments, BE protocol reviews,
comparative in vitro dissolution, CVM masking preferences, feed additives, and discussions with CMC on
the shift in stability format to XML, mechanical v. hand-splitting of tablets for studies, and more. Confirmed
agendas will be made available as soon as possible.
Questions? Call Kathy DeMarco, Executive Director, at GADA Headquarters:
2105 Laurel Bush Road, Suite 201, Bel Air, MD 21015-5200
Phone (443) 640-1046, ext. 119 Fax (443) 640-1043
Email: [email protected] www.gadaonline.org