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By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. The workshop is free to attend and available to all. More information on the Scientific Workshop can be found here and registration for the live-stream can be found here.
Over 100 biosimilar medicines are approved for nearly 30 reference medicines, testimony to the rigour of the scientific standards leading to the European authorisation process. This makes biosimilar medicines highly relevant. A significant number of the possible biosimilar candidates are not blockbuster medicines.
Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions: What are the latest legislative updates and proposed federal bills impacting PBM operations? You’ll hear from Matthew Gibbs, Pharm.D., And much more !
6 It also states that a multi-stakeholder workshop is being planned for Q3/Q4 of 2023, which will focus on promoting the development of psychedelics that address unmet medical needs. She has specialist expertise in patent litigation across both the telecommunications sector as well as pharmaceutical innovator and biosimilar sectors.
LANDSCAPE ADDRESS: Analyze Market Dynamics and Trends Impacting the Channel in an Ever-Changing Environment POLICY ADDRESS: Break Down Evolving Regulatory Reform Driving Innovation and Access Predict Novel Reimbursement Mechanisms and First Pharmacy Benefits for Biosimilars Download your copy of the agenda today and join Informa Connect in December!
Offer not valid on workshop only or academic/non-profit registrations. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *. Offer applies to current rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration.
Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects. Workshop: October 30th, 2020.
In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies and discussed potential barriers to their adoption. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).
Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.
This three-day summit will feature numerous presentations, workshops and networking opportunities featuring government officials, drug pricing and reimbursement lawyers and experts and industry leaders. A complete agenda is available here. Hyman, Phelps & McNamara, P.C.’s
Tackle the hottest topics facing industry right now, including: Keynote: The State of the Channel — Overview of Current and Future Trends Impacting the Channel Wall Street Insights — Analyze Market Dynamics and Key Investments in the Healthcare Ecosystem Focused Multi-Track Offerings: Supply Chain and Distribution Operations Pharmacy Model Strategies (..)
It also noted that last year, FDA hosted a two-day public workshop and published a white paper on the regulatory framework for Artificial Intelligence in drug manufacturing, in addition to other efforts. Like many of us, OPQ seems intent on trying to keep up with how technology can/will impact pharmaceutical quality.
By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.
The discussion moved on to a bio-similar competitive assessment case study, where Himanshu and Aditya presented a landscape of various biosimilars and their respective phases. They emphasized the importance of conducting a literature review and gap analysis for a clinical-stage company considering an investment in a molecule.
billion green loan to fund its purchase of Viatris’ biosimilars business. General Secretary at IDMA (Indian Drug Manufacturers Association), I am proud to say that IDMA has played a crucial role in this transition, organising workshops across the country in collaboration with the Central Drugs Standard Control Organisation (CDSCO).
FDA has also launched a series of five public workshops on issues related to DHTs in regulatory decision-making. FDA has created a DHT for Drug Development website and an email address for questions related to DHT-derived data ( dhtsfordrugdevelopment@fda.hhs.gov ).
The Institute of Chemical Technology, Mumbai, in partnership with the Mumbai Biocluster, hosted the 5th Annual Summit of Biologics Conference and Workshops on Biopharmaceutical Product Development from January 30th to 31st 2025.
To further expand patient input into product development, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products or “OTP” (formerly the Office of Tissues and Advanced Therapies, or “OTAT”) is holding a free public workshop titled, Clinical Trials: The Patient Experience.
CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.
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