Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date IND-Enabling Nonclinical Studies: Are You Prepared? William Salminen PhD, DABT, PMP Vice President, Premier Consulting; Andrew Emanuel Sr. Dir, Premier Partners Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clin... 2 weeks ago | 54 mins Navigating patients step by step on their clinical trial journey John Pinching, Kari Reilly, Kristin Faber and Adel Sepulveda For clinical trial participants, navigating their way through a study can sometimes seem daunting and complicated. Without the right support, around 3... 2 weeks ago | 61 mins IND-Enabling Nonclinical Studies: Are You Prepared? William Salminen PhD, DABT, PMP Vice President, Premier Consulting; Andrew Emanuel Sr. Dir, Premier Partners Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clin... 1 month ago | 54 mins Extending Hope: Broadening Access to CAR T-Cell Therapies Ayesha A. Pandit, M.D., M.S., MBA Vice President Oncology and Hematology Medical Affairs CAR T-cell therapies have transformed the therapeutic landscape for hematologic malignancies, offering substantial benefit to patients with few altern... 2 weeks ago | 40 mins IND에 필요한 비임상 연구 준비 William Salminen PhD, DABT, PMP Vice President, Premier Consulting; Andrew Emanuel Sr. Dir, Premier Partners 미국 식품의약국(FDA)의 임상시험계획 승인신청(IND)에 필요한 비임상 연구를 완료하는 것은 신약을 임상으로 진행하기 위한 중요한 단계입니다. 임상시험이 비임상시험 관리기준(GLP)과 같은 관련 규제 요건 및 FDA 및 국제의약품 규제조화 위원회의 지침에 따라 연구를... 1 month ago | 58 mins An inside guide to unlocking clinical research in the UK – PART 2 Jennifer Harris ABPI, Laura Bousfield NIHR, Matthew Snape Moderna, Professor Philip Evans NIHR, Eloise (pharmaphorum) Right research, right place, right time - this session focuses on how to place your study more strategically to optimise study performance. 2 months ago | 61 mins Extending Hope: Broadening Access to CAR T-Cell Therapies Ayesha A. Pandit, M.D., M.S., MBA Vice President Oncology and Hematology Medical Affairs CAR T-cell therapies have transformed the therapeutic landscape for hematologic malignancies, offering substantial benefit to patients with few altern... 1 month ago | 40 mins Improving the Clinical Trial Experience: Why, How, and What? Sofia Fionda, Jonathan Moshinksy and Harry Yeates Clinical trials don’t happen in a vacuum – they are often a significant undertaking that require people to integrate new routines and procedures into ... 3 months ago | 60 mins Mastering 505(b)(2) Drug Development:Strategic Pillars & Bridging Considerations William Salminen Ph.D. DABT PMP VP Premier Consulting ; Seth D. DePuy, PhD Manager, Regulatory Affairs Premier Consulting Join us for a comprehensive webinar that delves into the intricacies of successful drug development under the 505(b)(2) pathway. In addition, this web... June 29, 2023 10:30am Mastering 505(b)(2) Drug Development:Strategic Pillars & Bridging Considerations William Salminen Ph.D. DABT PMP VP Premier Consulting ; Seth D. DePuy, PhD Manager, Regulatory Affairs Premier Consulting Join us for a comprehensive webinar that delves into the intricacies of successful drug development under the 505(b)(2) pathway. In addition, this web... June 29, 2023 4:00am Load more
