BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The Center for Research on Complex Generics (CRCG) - ECPv6.14.1//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:The Center for Research on Complex Generics (CRCG) X-ORIGINAL-URL:https://www.complexgenerics.org X-WR-CALDESC:Events for The Center for Research on Complex Generics (CRCG) REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD TZOFFSETFROM:+0000 TZOFFSETTO:+0000 TZNAME:UTC DTSTART:20260101T000000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=UTC:20260923T083000 DTEND;TZID=UTC:20260924T173000 DTSTAMP:20260614T224729 CREATED:20250918T215130Z LAST-MODIFIED:20260604T224411Z UID:38345-1790152200-1790271000@www.complexgenerics.org SUMMARY:Navigating the GLP-1 Generic Drug Pathway DESCRIPTION:Navigating the GLP-1 Generic Drug Pathway\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop \n\n\n\n \n \n \n \n \n Registration Now Open\n \n \n \n \n \n \n \n Register here \n \n \n \n \n \n \n\n\n\nAboutEvent OutlineTravel & AccomodationsOrdering Lunch\n \n This two-day workshop will address some of the key product development and regulatory assessment considerations for generic glucagon-like peptide-1 (GLP-1) agonist products. The goal of this workshop is to provide clarity and foster discussions on evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic peptide products\, address manufacturing quality considerations\, and tackle the unique challenges associated with drug-device combination products\, where applicable. \nKey areas of focus include: \n\nRegulatory and Scientific Foundations: Current FDA scientific thinking on generic GLP-1 product development\, Product-Specific Guidance (PSG) development\, and in vivo BE studies for GLP-1 oral products\nActive Pharmaceutical Ingredient (API) Characterization and Manufacturing: Comprehensive approaches to demonstrating API sameness\, analytical characterization strategies\, impurity profiling\, and sameness assessment for peptide products\nRecombinant Peptide Production: Best practices for controlling host cell impurities\, regulatory expectations\, and risk assessment strategies\nOral GLP-1 Formulation Development: Formulation and delivery innovations\, bioequivalence study design for highly variable products\, absorption enhancement technologies\, and drug product quality expectations\nDevice User Interface and Human Factors: Comparative analyses (CA) of device user interfaces\, Comparative Use Human Factors (CUHF) study design and case examples\, alternative approaches\, and device platform strategies\nDevice Quality and Integration: Quality considerations for generic injectors\, drug-device interface and compatibility\, manufacturing quality control\, and submission coordination strategies\n\nJoin us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies\, pharmaceutical industry\, and academia. All attendees will benefit from insights shared by a diverse group of speakers\, including FDA officials\, industry leaders\, and renowned academics. This workshop offers a unique opportunity to: \n\nUnderstand the latest regulatory thinking on generic GLP-1 product development\nLearn about cutting-edge analytical and formulation approaches for peptide products\nGain insights into device design\, human factors\, and combination product development\nNetwork with peers and experts in the field\nExplore real-world case examples and best practices\nParticipate in collaborative discussions on emerging challenges\n\nJoin us to be part of the conversation shaping the future of generic GLP-1 product development. \nChoose your experience: \nVirtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to: \n\nAttend all presentations and panel discussions\nParticipate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists\nEnjoy free access to workshop recordings of presentations and panel discussion (not including the small group working sessions)\n\nIn-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring: \n\nSmall group working sessions at the end of each day will facilitate collaborative problem-solving and discussion of complex technical and regulatory issues impacting GLP-1 generics. During these working sessions\, attendees will help identify actionable next steps to address challenges with generic product development and regulatory assessment.\nCollaborative interactions with experts from industry\, consulting groups\, academia and FDA for clarifying regulatory expectations and exploring insights into regulatory standards\nNetworking opportunities designed to foster collaboration and contribute to moving the field forward.\n\nWorkshop Topics\n\nRegulatory Pathways and Clinical Context\nAPI Characterization and Peptide Manufacturing\nOral Formulation Development and Bioequivalence\nDevice Design and Human Factors\nDrug-Device Integration and Quality\n\nAudience\nThis workshop is designed for professionals involved in the development\, manufacturing\, and regulation of generic GLP-1 products. The target audience includes pharmaceutical scientists (formulation and product development scientists\, analytical chemists\, quality assurance and control experts)\, regulatory affairs professionals\, device engineers\, human factors specialists\, clinical development professionals\, and manufacturing experts. Additionally\, the workshop will be valuable for academic researchers in pharmaceutical sciences\, representatives from contract research organizations (CROs) and contract manufacturing organizations (CMOs)\, regulatory agency staff\, and healthcare professionals interested in generic complex drug products. The content is tailored to accommodate participants with varying levels of expertise in peptide products and drug-device combination products\, from those seeking to understand the fundamentals to advanced practitioners looking to stay abreast of the latest regulatory considerations and development strategies. \n\nVirtual Attendance is optimal for an audience who would like to have access to workshop content from anywhere\, eliminate travel time and expenses\, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.\nIn-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement\, immersive learning\, interactive sessions and group activities.\n\nRegistration Fees: \n\nThis workshop is FREE for virtual attendees.\n\n\nThe combined cost for both days of in-person attendance and activities is:\n\n$350\, in-person attendees – general\n$150\, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)\n\n\n\nFor faculty and students from the University of Maryland\, Baltimore\, The Universities at Shady Grove\, and University of Michigan\, please contact CRCG (info@complexgenerics.org) regarding registration. \nContinuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person\, when requested. \n\n\n\n\n\n\n\n\n \n Introduction to the Workshop \nThis two-day hybrid (virtual and in-person) workshop focuses on exploring the scientific\, regulatory\, and technical considerations for developing generic GLP-1 products throughout development. The workshop will include comprehensive sessions examining regulatory pathways and clinical context\, API characterization and manufacturing\, oral formulation development\, device design and human factors\, and drug-device integration strategies. The program features expert presentations from regulatory scientists across multiple FDA offices\, industry leaders from both innovator and generic companies\, device manufacturers\, and academic researchers\, complemented by interactive Q&A panels and small working group discussions for in-person attendees at the end of each day. This collaborative forum aims to advance understanding of the unique challenges in generic GLP-1 development and foster dialogue on best practices\, emerging approaches\, and regulatory expectations for these complex products. \nDAY 1\nSession 1: Opening Remarks and Regulatory Foundations \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis opening session establishes the regulatory and clinical framework for generic GLP-1 product development. The session provides an overview of the currently available GLP-1 products for generic products to reference. It will also explore the economics and patent landscape of GLP-1 products\, providing essential background for understanding the market dynamics and development considerations.\n\nSession 2: API Characterization and Sameness Demonstration \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session establishes regulatory expectations and scientific approaches for demonstrating API sameness in generic GLP-1 peptide products. Topics include structural and functional equivalence demonstration\, comprehensive analytical characterization strategies (including higher-order structure analysis and mass spectrometry)\, peptide-specific stability challenges and shelf-life determinations\, impurity profiling and characterization\, and an update on peptide impurity qualification. The session will address common deficiencies and provide practical guidance on analytical methods and data requirements.\n\nSession 3: Recombinant Peptide Production and Host Cell Impurities \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session examines best practices for controlling host cell impurities in recombinant peptide production\, drawing on regulatory expectations and experience from 505(b)(2) applications and biologics (including insulins). Attendees will learn about manufacturing considerations for recombinant peptides\, analytical approaches for host cell protein detection and quantification and regulatory expectations for impurity control and cleanup processes.\n\nSession 4: Small Group Working Sessions \nFormat: Interactive Working Sessions Around a Roundtable (In-Person Only) \n\nIn this interactive and collaborative session\, in-person attendees will participate in focused discussions on key topics from Day 1\, including API characterization challenges\, analytical method development\, stability strategies\, and manufacturing considerations. Guided by experienced moderators\, participants will engage in immersive round-table deliberations on selected high-impact topics\, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include API characterization and demonstrations of sameness\, as well as recombinant peptide production and host cell impurities.\n\nDAY 2\nSession 5: Device Design\, User Interface\, Human Factors\, and Quality \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session examines how device user interface differences in GLP-1 products affect substitutability\, bioequivalence\, and FDA expectations for Comparative analyses (CA) and Comparative Use Human Factors (CUHF) studies\, and addresses device engineering and drug-device compatibility considerations that impact performance\, bioequivalence\, and ANDA review for GLP-1 generic combination products. Topics include the landscape of GLP-1 drug-device combination products in the US market\, regulatory framing of “acceptable” UI differences\, current CUHF study guidance and design fundamentals\, case examples for pen injectors and autoinjectors\, alternative CUHF approaches\, device platform-based approaches for CA and HF data sharing\, engineering considerations for generic GLP-1 injectors and drug-device interfaces\, and CMC considerations for device evaluation. The session provides practical insights into study design\, recruitment challenges\, and regulatory expectations for developing robust GLP-1 generic combination products.\n\nSession 6: Oral Semaglutide: Bioequivalence\, Regulatory Considerations\, and Oral Peptide Delivery \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session addresses the regulatory and scientific challenges of developing generic oral semaglutide tablets\, drawing on FDA’s experience with PSG development and generic application review. Topics include PSG development and bioequivalence study design\, strategies for managing high intrasubject pharmacokinetic variability\, FDA perspectives on drug product specifications and quality expectations\, clinical considerations for oral peptide formulation approaches\, and permeation enhancer selection for oral peptide delivery. Together\, these presentations provide practical insights into the unique challenges of developing generic oral semaglutide products and the evolving landscape of oral peptide delivery technologies.\n\nSession 7: Small Group Working Sessions – Day 2 \nFormat: Interactive Working Sessions Around a Roundtable (In-Person Only) \n\nIn this interactive and collaborative session\, in-person attendees will participate in focused discussions on key topics from Day 2\, including oral formulation challenges\, device design considerations\, human factors study approaches\, and combination product development strategies. Guided by experienced moderators\, participants will engage in immersive round-table deliberations on selected high-impact topics\, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include CUHF study challenges\, subgroup analysis and extrapolation\, device platform approaches\, and submission coordination strategies.\n\nThe workshop will conclude with a summary of key takeaways and future directions for generic GLP-1 product development. \n\n\n\n\n\n\n \n \n \n Location\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n \nTravel 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.\nAs 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.\nThe 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.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor 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.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n Train tickets (Omio) \n\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi\, Car\, Uber\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094 \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \nUber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Sept. 1\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville\n1775 Rockville Pike\, Rockville MD 20852 (5.5 miles from USG)\n855-879-3836\n\n\n \n \n\n\n\n\n \n For the September 23-24 workshop\, you will need to pre-order your lunch for each day; lunch is not provided.  Lunch will be delivered to the main building where the workshop will be held (Building II\, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk\, each day.  \nYou can go to Dawson’s Market as well\, located in Building III\, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch\, as well. \nLink for Wednesday\, September 23:  https://square.link/u/v9xMwlxI \nLink for Thursday\, September 24:  https://square.link/u/tRQgNkZk \nMake your selection and Add to Order.  Once you have made your selection\, you will then click on the shopping cart icon to check out.  If you want to purchase more than one meal for the same day\, you will need to place two separate orders.  You will Continue to Payment\, where you can pay with Google Pay\, Credit Card\, or Cash App Pay.  Then hit Place Order. \nDuring checkout\, there is a spot for Note to Seller\, to use when placing your order\, if needed for modifications to your order. \nThe deadline for ordering lunch is Monday\, September 14th by 5 PM ET. \nCoffee\, hot tea\, water\, and soft drinks will be available throughout each day in the conference room (Ballroom).  \nFood will be provided in the morning\, and AM and PM breaks each day. \nUSG Lunch (Dawson’s Market) \nChicken Caesar Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTurkey & Swiss Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTuna Salad Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nGrilled Vegetables & Hummus Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nEggless Egg Salad Wrap (VEGAN) $14.99 Includes chips\, cookie\, and choice of beverage \nYou will have the option to remove tomatoes and/or cheese\, if needed \nGreek Salad $14.99 Includes romaine lettuce\, tomatoes\, onion\, kalamata olives\, bell peppers\, feta cheese\, pepperoncini peppers served with Dijon vinaigrette. Includes chips\, cookie\, and choice of beverage \nGrilled Salmon Caesar Salad $15.99 Includes chopped romaine\, house made croutons\, shredded parmesan & Caesar dressing. Includes chips\, cookie\, and choice of beverage \nGoat & Greens $14.99 Includes spinach\, cranberries\, pecans\, tomatoes\, goat cheese served with balsamic vinaigrette. Includes chips\, cookie\, and choice of beverage \nHot Items \nTomato Basil Soup  $6.99 \nTaco Bowl  $15.99 Your choice of [fajita chicken\, ground beef\, or vegetables] on a bed of rice with mixed greens\, fajita vegetables\, black beans\, shredded cheese\, and toppings on the side (guacamole\, sour cream\, and salsa) \nBeverage Choice \nCoke \nDiet Coke \nSprite \nWater \nJust Tea-Mango White (additional $1.00) \nJust Tea-Original Green (additional $1.00) \nJust Tea-Half & Half (additional $1.00) \nDr. Browns-Cream \nDr. Browns-Black Cherry \nDr. Browns-Root Beer \nOlipop-Grape (additional $1.00) \nOlipop-Ginger Lemon (additional $1.00) \nOlipop-Cherry Cola (additional $1.00) URL:https://www.complexgenerics.org/education-training/navigating-the-glp-1-generic-drug-pathway/ ATTACH;FMTTYPE=image/jpeg:https://www.complexgenerics.org/wp-content/uploads/2026/05/GLP-1-Conference-image.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20261014T083000 DTEND;TZID=UTC:20261015T173000 DTSTAMP:20260614T224729 CREATED:20250918T215559Z LAST-MODIFIED:20260225T193123Z UID:38348-1791966600-1792085400@www.complexgenerics.org SUMMARY:Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods DESCRIPTION:Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop. \n\n\n\n \n \n \n \n \n Registration Coming Soon\n \n \n \n \n \n \n \n \n \n\n\n\nAboutTravel & Accommodations\n \n The transition of BE recommendations for locally-acting inhalation and nasal products to option-based frameworks has opened new opportunities by incorporating innovative in vitro\, in vivo\, and in silico methods as alternatives to comparative clinical endpoint BE studies. These advanced methodologies offer promising pathways for more efficient generic product development\, though they require thoughtful implementation to maximize their potential. This workshop will harness collective expertise to identify best practices and develop strategic approaches that optimize study design\, eliminate redundancies\, and enhance evaluation efficiency—ultimately supporting first cycle approvals while addressing unique considerations for products with compositional differences. \n\n\n\n\n\n\n \n \n \n Location\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n Directions and Transportation \n\nTravel 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.\nAs 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.\nThe 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.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor 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.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n \nTrain tickets (Omio)\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi\, Car\, and Uber\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094 \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \nUber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Sept. 22\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville \n\n1775 Rockville Pike\, Rockville\, MD 20852 (5.5 miles from USG)\n855-879-3836 URL:https://www.complexgenerics.org/education-training/advancing-bioequivalence-frameworks-for-inhalation-and-nasal-drug-products-optimizing-in-vitro-in-vivo-and-in-silico-methods/ ATTACH;FMTTYPE=image/jpeg:https://www.complexgenerics.org/wp-content/uploads/2023/11/crcg-logo.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20261201T083000 DTEND;TZID=UTC:20261202T173000 DTSTAMP:20260614T224729 CREATED:20250918T220039Z LAST-MODIFIED:20260225T193700Z UID:38351-1796113800-1796232600@www.complexgenerics.org SUMMARY:Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment DESCRIPTION:Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop. \n\n\n\n \n \n \n \n \n Registration Coming Soon\n \n \n \n \n \n \n \n \n \n\n\n\nAboutTravel & Accommodations\n \n The purpose of this 2-day workshop is to facilitate an in-depth look at current challenges relating to LAI product characterization\, drug release mechanisms\, in vivo BE study conduct\, and factors that impact product development and regulatory assessment. The workshop will discuss current thinking on LAI drug release mechanisms\, in vitro methodologies\, and predictive modeling approaches to support LAI generic drug development and regulatory assessment. Sessions will discuss common deficiencies observed during ANDA assessment\, alternative BE study designs\, and model-integrated evidence approaches that enable a more efficient and feasible BE assessment. The workshop will also facilitate a discussion about permissible formulation differences and their impact on product performance\, reverse engineering approaches\, and novel excipient evaluation strategies. \n\n\n\n\n\n\n \n \n \n Location\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n \nTravel 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.\nAs 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.\nThe 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.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n  \n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor 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.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n \nTrain tickets (Omio)\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi\, Car\, and Uber\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094 \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \nUber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Nov. 9\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville \n\n1775 Rockville Pike\, Rockville\, MD 20852 (5.5 miles from USG)\n855-879-3836 \n  URL:https://www.complexgenerics.org/education-training/long-acting-injectable-lai-generics-navigating-technical-hurdles-in-product-development-and-regulatory-assessment/ ATTACH;FMTTYPE=image/jpeg:https://www.complexgenerics.org/wp-content/uploads/2023/11/crcg-logo.jpg END:VEVENT END:VCALENDAR