Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products
Date and Time:
November 19, 2025
, 8:30 am –
5:30 pm ,
November 20, 2025
, 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 field of generic ophthalmic drug products is rapidly evolving, with increasing complexity in drug product formulations and devices, leading to challenges in assessing performance sameness and ensuring quality. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic development and regulatory assessment.
Attendees will gain valuable insights into the intricacies of developing ophthalmic products, including insertable, implantable, and topical ophthalmic therapies. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with regulators, industrial peers, and academic experts in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends.
Specifically, the workshop will cover critical issues such as in vitro drug release testing, qualitative (Q1) and quantitative (Q2) sameness of polymers in ophthalmic products, formulation characterization, considerations for clinical bioequivalence studies, and the challenges encountered when developing or assessing prospective generic ophthalmic products.
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 u003ca href=u0022https://shadygrove.umd.edu/u0022u003eu003cstrongu003eUniversities at Shady Grove (USG)u003c/strongu003eu003c/au003e.rnrnAddress: Ballroom (u003cemu003eplease follow signsu003c/emu003e), 9630 Gudelsky Drive Building II, Rockville, MD 20850
u003culu003ern tu003cliu003eTravel 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.u003c/liu003ern tu003cliu003eAs there is road traffic in the region, the fastest way to the Shady Grove campus is the DCA airport, then taking the Metro subway from the airport to Shady Grove, 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.u003c/liu003ern tu003cliu003eThe Metro subway serves DCA and IAD airports, which connects with the Shady Grove 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.u003c/liu003ernu003c/ulu003ernu003cstrongu003eMore links and information:u003c/strongu003ernu003culu003ern tu003cliu003eu003ca href=u0022https://shadygrove.umd.edu/about-usg/directions-transportationu0022u003eu003cstrongu003eDirections and transportation options to USGu003c/strongu003eu003c/au003eu003c/liu003ern tu003cliu003eu003ca href=u0022https://shadygrove.umd.edu/about-usg/directions-transportation/public-transportationu0022u003eu003cstrongu003ePublic transportationu003c/strongu003eu003c/au003eu003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://shadygrove.umd.edu/sites/default/files/u81/basic-page/USG%202D%20Map%20-%207_06_22.pdfu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eCampus mapu003c/au003eu003c/strongu003eu003c/liu003ernu003c/ulu003ernu0026nbsp;
u003culu003ern tu003cliu003eThe Traville-Gateway Garage is the closest parking garage to the venue (u003cstrongu003eu003ca href=u0022https://www.complexgenerics.org/media/SOP/complexgenerics/shady-grove-parking-map.pngu0022u003eparking mapu003c/au003eu003c/strongu003e)u003cstrongu003e.u003c/strongu003e Attendees may also park in the Shady Grove Garage but will need to allow more walking time to reach the event.u003c/liu003ern tu003cliu003ernu003cdivu003eVisitor 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.u003c/divu003eu003c/liu003ern tu003cliu003eGuests are responsible for the cost of parking; parking will not be validated. Parking is $15 for all day.u003c/liu003ernu003c/ulu003ernClick for u003ca href=u0022https://shadygrove.umd.edu/about-usg/directions-transportation/parkingu0022u003eu003cstrongu003eparking informationu003c/strongu003eu003c/au003e from the USG website.
Please click on the following u0022all transportation optionsu0022 links to find transportation from the airport via subway, bus, taxi, car, and town car.rnu003culu003ern tu003cliu003eReagan National Airport (DCA): 21.1 miles from Rockville, Md. (u003ca href=u0022https://www.rome2rio.com/s/Reagan-Washington-Airport-DCA/Rockville?source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLcyy7zQozMbmmFpJCht7V5khU-X3bfr2soXFGfS0em3lADxGwG9sN0aArAyEALw_wcBu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003eall transportation options from DCAu003c/strongu003eu003c/au003e) (u003ca href=u0022https://www.rome2rio.com/map/Reagan-Washington-Airport-DCA/Rockville?source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLcyy7zQozMbmmFpJCht7V5khU-X3bfr2soXFGfS0em3lADxGwG9sN0aArAyEALw_wcB#r/Subwayu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003etrain options from DCAu003c/strongu003eu003c/au003e)u003c/liu003ern tu003cliu003eDulles International Airport (IAD): 27.8 miles from Rockville, Md. (u003ca href=u0022https://www.rome2rio.com/s/Washington-Dulles-Airport-IAD/Rockville?source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLcY1Bn3sf8YtoWhzD4xWGza_huRkf4Xg5fkFa8gX4UgJXtGAEIkvacaAk2KEALw_wcBu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003eall transportation options from IADu003c/strongu003eu003c/au003e) (u003ca href=u0022https://www.rome2rio.com/map/Washington-Dulles-Airport-IAD/Rockville?source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLcY1Bn3sf8YtoWhzD4xWGza_huRkf4Xg5fkFa8gX4UgJXtGAEIkvacaAk2KEALw_wcB#r/Subwayu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003etrain options from IADu003c/strongu003eu003c/au003e)u003c/liu003ern tu003cliu003eBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville, Md. (u003ca href=u0022https://www.rome2rio.com/s/Baltimore-Airport-BWI/Rockville?source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLfr4tJsm8lyehKLxUWCDd37DOw5KAlFJcrBdeOkMpmfYHiPpLU2Q9kaAu-SEALw_wcBu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003eall transportation options from BWIu003c/strongu003eu003c/au003e) (u003ca href=u0022https://www.rome2rio.com/map/Baltimore-Airport-BWI/Rockville?r2r_campaign=TQ_TP_Transportu0026amp;source=adwordsu0026amp;gclid=Cj0KCQiA_bieBhDSARIsADU4zLf11hqnfWf-IWVoi4n6rO_S8GrvBRmUbsfQl1jXu-er2h_AIfObX-waAr4sEALw_wcB#r/Train-subwayu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003etrain options from BWIu003c/strongu003eu003c/au003e)u003c/liu003ernu003c/ulu003e
u003culu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.omio.com/trains/washington-dc/baltimore-mdu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTrain tickets (Omio)u003c/au003eu003c/strongu003eu003c/liu003ern tu003cliu003eWashington, DC to Baltimore: Approximately 35 minutesu003c/liu003ern tu003cliu003ePenn Station Marc SB (Baltimore): Approximately 41 miles from campusu003c/liu003ernu003c/ulu003e
u003cemu003eGuests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts.u003c/emu003ernrnThere are many hotels within a short driving distance to the USG campus including:rnu003culu003ern tu003cliu003eu003ca href=u0022https://www.hilton.com/en/hotels/dcarvgi-hilton-garden-inn-rockville-gaithersburgu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003eHilton Garden Inn Rockville-Gaithersburgu003c/strongu003eu003c/au003e (u003ca href=u0022https://www.hilton.com/en/attend-my-event/characterizationofcomplexexcipients/u0022u003ebook using our reduced rateu003c/au003e by Dec. 10, 2023)rn14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)rn240-507-1800u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.hilton.com/en/hotels/rvchmhw-homewood-suites-rockville-gaithersburgu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eHomewood Suites by Hilton Rockville-Gaithersburgu003c/au003eu003c/strongu003ern14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)rn240-507-1900u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.marriott.com/en-us/hotels/wasrv-courtyard-rockvilleu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eCourtyard by Marriott Rockvillernu003c/au003eu003c/strongu003e2500 Research Boulevard, Rockville, MD 20850 (0.9 miles from USG)rn301-670-6700u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.choicehotels.com/maryland/rockville/sleep-inn-hotels/md619u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eSleep Inn Rockvilleu003c/au003eu003c/strongu003ern2 Research Ct., Rockville, MD 20850 (1.2 miles from USG)rn301-507-8000u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.wyndhamhotels.com/en-ca/ramada/rockville-maryland/the-rockville-hotel-a-ramada/overview?CID=LC:RA::GGL:RIO:National:49872u0026amp;iata=00093796u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eThe Rockville Hotel, a Ramada by Wyndhamu003c/au003ernu003c/strongu003e3 Research Ct., Rockville, MD 20850 (1.2 miles from USG)rn301-202-1098u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.marriott.com/en-us/hotels/wasgt-springhill-suites-gaithersburg/overview/?scid=f2ae0541-1279-4f24-b197-a979c79310b0u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eSpring Hill Suites by Marriott Gaithersburgu003c/au003ernu003c/strongu003e9715 Washingtonian Blvd, Gaithersburg, MD 20878 (1.4 miles from USG)rn301-987-0900u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.marriott.com/en-us/hotels/wasvs-sheraton-rockville-hotel/overview/?scid=f2ae0541-1279-4f24-b197-a979c79310b0u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eSheraton Rockville Hotelu003c/au003ernu003c/strongu003e920 King Farm Blvd, Rockville, MD 20850 (1.4 miles from USG)rn240-912-8200u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.marriott.com/en-us/hotels/wascg-courtyard-gaithersburg-washingtonian-center/overview/?scid=f2ae0541-1279-4f24-b197-a979c79310b0u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eCourtyard by Marriott Gaithersburg Washingtonian Centeru003c/au003ernu003c/strongu003e204 Boardwalk Place, Gaithersburg, MD 20878 (1.6 miles from USG)rn301-527-9000u003c/liu003ern tu003cliu003eu003cstrongu003eu003ca href=u0022https://www.choicehotels.com/maryland/gaithersburg/comfort-inn-hotels/md413u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eComfort Inn Shady Grove-Gaithersburg-Rockvilleu003c/au003ernu003c/strongu003e16216 Frederick Rd., Gaithersburg, MD 20877 (2.2 miles from USG)rn301-330-0023u003c/liu003ernu003c/ulu003e
