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DTSTART;VALUE=DATE:20240123
DTEND;VALUE=DATE:20240126
DTSTAMP:20260516T013357
CREATED:20230927T095451Z
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SUMMARY:Gene Therapy Regulatory Affairs Summit
DESCRIPTION:With 2023 welcoming newly FDA-approved gene therapies from BioMarin\, Krystal Biotech and Sarepta Therapeutics\, many more treatments are hot on their heels for approval\, investment is pouring into developing gene therapies and the role of regulatory affairs has never been more important. \nAs the first ever regulatory affairs forum wholly dedicated to gene therapy\, this meeting uniquely unites regulatory bodies and the leading regulatory personnel across big pharma and innovative biotech to discuss the hottest topics\, identify industry bottlenecks and offer actionable insights. \nJoin 80+ industry leaders from 4D Molecular Therapeutics\, Advanced Cell & Gene Therapy\, Adverum Biotechnologies\, Astrazeneca\, Bridge Bio\, Health Canada\, Omega Therapeutics\, Opus Genetics\, Regeneron Pharmaceuticals\, Sangamo Therapeutics\, Solid Biosciences\, Spark Therapeutics\, Ultragenyx Pharmaceutical\, and more… \nBy attending this summit\, you will get a chance to: \n\nUnderstand the nuanced differences and the route to harmonization in global regulation across the EMA\, MHRA\, FDA & Health Canada\nHone your regulatory intelligence\, understand how to use biomarkers as surrogate endpoints and perfect clinical trial strategy for regulatory success\nExplore the next steps for specific technologies beyond AAV and novel regulatory route\nHear from the regulators in the Health Canada and the FDA to have your queries clarified\n\nOvercome your CMC hurdles to prove the efficacy\, purity & comparability of your compound to avoid later setbacks in poor manufacturing preparation \nDon’t miss out on this unrivalled opportunity to inform your trial design\, perfect your CMC approach and supercharge your global submission strategy for regulatory success. \nDownload the full agenda here to see our full speaker faculty\, 3-day agenda and audience breakdown: https://ter.li/sgkcr9
URL:http://www.pharmajournalist.com/event/gene-therapy-regulatory-affairs-summit/
LOCATION:Boston Park Plaza\, 50 Park Plaza\, Boston\, MA\, 02116\, United States
ORGANIZER;CN="Hanson Wade":MAILTO:info@hansonwade.com
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DTSTART;VALUE=DATE:20240123
DTEND;VALUE=DATE:20240126
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CREATED:20231006T112619Z
LAST-MODIFIED:20231006T112619Z
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SUMMARY:3rd mRNA-Based Therapeutics Summit Europe
DESCRIPTION:250+ mRNA Specialists | 40+ World-Class Speakers | 2 Streams of Content \nThe 3rd mRNA-Based Therapeutics Summit Europe returns to Berlin this 23rd-25th January to unite European biopharma\, to hear from the likes of BioNTech\, CureVac\, Moderna\, Pfizer\, Ethris\, Sanofi\, and regulatory insights for the MHRA and EMA. \nDownload the full brochure here: https://ter.li/1329up \nThis is your opportunity to hear the hottest content of the mRNA world\, deep diving into two content tracks on Translational Development and CMC\, a pre-conference Focus Day on AI RNA Design & Delivery\, and three immersive pre-conference workshops. \nJoin in January to understand the roadmap towards clinical success and regulatory approval\, and deliver the promise of better mRNA medicines to patients faster. \nBook your place here: https://ter.li/qu2h8f
URL:http://www.pharmajournalist.com/event/3rd-mrna-based-therapeutics-summit-europe/
LOCATION:Mecure Hotel MOA Berin\, Stephanstraße 41\, Berlin\, 10559\, Germany
ORGANIZER;CN="Hanson Wade":MAILTO:info@hansonwade.com
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