Basics of NDA Submission and Post-marketing Regulatory Requirements

Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

What you will learn
• Overview and roles and responsibilities of FDA
• NDA in CTD format
• Regulatory compliance and FDA inspections
• Post-approval regulatory requirements for NDAs
• Regulatory requirements for prescription drug/biologics labeling
• Regulatory requirements for prescription drug/biologics advertising
• How to interact with the FDA

TRAVEL AND HOTEL INFORMATION
Hotel reservations should be made ONLY after receipt of written registration confirmation from DIA.

TRAINING COURSE LOCATION
DIA Worldwide Headquarters
800 Enterprise Road; Suite 101
Horsham, PA 19044

HOTEL LOCATION
Joseph Ambler Inn
1005 Horsham Road
North Wales, PA 19454-1413 USA

Travel Information
Tucked away on 12 acres of rolling countryside, the Joseph Ambler Inn offers the exceptional features expected of a great country inn including an award-winning Pennsylvania restaurant and 52 pampering B&B guestrooms. Surrounded by peaceful meadows and comprising 5 historic buildings, the inn’s facilities and grounds are unmatched in all of Bucks and Montgomery counties.
Just 45 minutes from Philadelphia, the Joseph Ambler Inn is centrally located to the attractions and activities of the area.  Valley Forge National Park, New Hope, and Bucks County are just a one-hour drive. Day trips can be made to Atlantic City casinos, Lancaster County Amish Country, and Reading, the shopping outlet headquarters.

Hotel Information
A limited block of rooms has been reserved at the Joseph Ambler Inn at a low rate per night until the release date of October 18, 2010. We urge you to make your hotel reservations early and plan on staying at the hotel in order to facilitate interactive discussion with faculty and fellow participants.

Single $127 Double $127

Attendees must make their own hotel reservations. To reserve your room, contact the Joseph Ambler Inn by telephone at 215-362-7500 and mention the DIA Training Course.

Participants with disabilities: DIA meeting facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the meeting if requested at least 15 days prior to meeting. Contact the DIA office to indicate your needs.