Modeling and Artificial Intelligence (AI) in Generic Drugs: Regulatory Insights and Future Trends

Date and Time: October 15 , 8:30 am  –  5:30 pm ,
October 16 , 8:30 am  –  5:30 pm

Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)

In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.

Registration Coming Soon

The purpose of this workshop is for interested parties from industry, academia, and other groups interested in the development of complex generic products to collaborate to discuss the concept, scope, and scientific/regulatory considerations of using modeling and AI for generic drug product development and assessment.

In the past ten years there have been unprecedented advancements and successes in AI and modeling across many fields, including deep learning, reinforcement learning, and groundbreaking achievements like AlphaGo, AlphaFold, and ChatGPT. These developments present tremendous opportunities for generic drug development, regulatory assessment, and decision-making.

The information exchange and discussions during the workshop will foster a shared understanding of the role modeling and AI play in advancing drug product development, enhancing regulatory consistency and efficiency, and streamlining drug product approval.

For more information about these events, as well as other FDA and CRCG collaborative activities, visit http://www.complexgenerics.org/.

The workshop will be held at the Universities at Shady Grove (USG).

Address: Ballroom (please follow signs in the hallway), 9630 Gudelsky Drive, Building II, Rockville, MD 20850

  • The Traville-Gateway Garage is the closest parking garage, and recommended, to the venue (parking map).  Attendees can only park in the following locations:  Traville-Gateway garage parking (Levels 2-6), Lot 2, and the Shady Grove garage (campus map).  If you park in other areas, you may be ticketed.  CRCG will not cover parking tickets.
  • Visitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.
  • Guests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.

Click for parking information from the USG website.

Directions and Transportation

  • Travel from local airports to Rockville, MD (The Universities at Shady Grove (USG)) will require an Uber or Lyft, which is by far the best way to obtain car service.
  • As there is road traffic in the region, the fastest way to the USG campus is the DCA airport, then taking the Metro subway from the airport to USG, then taking Uber or Lyft. Alternatively, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport, we suggest taking Uber or Lyft to USG.
  • The Metro subway serves DCA and IAD airports, which connects with the USG stop on the red line. If flying into IAD, taking the Metro will save some cost, but will probably take extra time, even if traffic is heavy.

Please click on the following “all transportation options” links to find transportation from the airport via subway, bus, taxi, car, and town car.

Train tickets (Omio)

  • Washington, DC to Baltimore: Approximately 35 minutes
  • Penn Station Marc SB (Baltimore): Approximately 41 miles from campus

Bob’s Limo Service (Email): 301-525-2525

B&B Executive Sedan (Email): 240-533-6262

East Coast Limousine (Email): 301-527-0413 or 240-793-8196

Uber: Baltimore, BWI Airport, Washington, DC, Dulles (IAD) Airport

Guests should mention they are attending a conference at The Universities at Shady Grove; most hotels offer discounts.

There are many hotels within a short driving distance to the USG campus including: