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 New-Drug Development: Succeeding With the FDA Premier Research Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 7 days ago | 43 mins Regulatory Considerations for Working with the FDA vs. the EMA Premier Consulting – Kimberly Cummings, Vice President, Regulatory Affairs, & Maurice Bancsi, Director, Regulatory Affairs This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more. We will discuss: –... 1 week ago | 60 mins Modernising haematological malignancy adverse event assessment and reporting Lan-Lan Smith, Gita Thanarajasingam Targeted agents, immune and cellular therapies and other novel agents have led to dramatic shifts in the treatment of many hematologic malignancies (H... 3 months ago | 63 mins Sepsis Overview: Challenges and Solutions for Laboratories Mirta Gamez, M.T.(A.S.C.P.), C.L.S. Sepsis presents a global healthcare crisis, with more people dying from sepsis than from prostate cancer, colon cancer, breast cancer and AIDS combine... 3 years ago | 51 mins 속도 대 안전: 규제기관은 오늘날 어떻게 증거를 평가하는가 Premier Research 신약 개발 과정에서는 언제나 빨리 진행해야 한다는 압박이 있고, COVID에 대한 치료제와 백신을 개발해야 한다는 압력과 함께 이러한 압박이 더 거세졌습니다. 의뢰자, 시험자, 규제당국까지, 모두가 속도와 안전이라는 두 마리 토끼를 모두 잡으려 하고 있습니다. 만약 성... 3 months ago | 31 mins 2D Ex Vivo Patient-derived AML Platform for testing Molecular-Targeted Therapies Bandana Vishwakarma, PhD, Scientist in Hematology Oncology at Champions Oncology Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availab... 2 years ago | 22 mins Addressing Challenges in Bringing Male Contraceptives to Market Premier Research There are currently more than a dozen categories of female birth control with proven efficacy on the market. Conversely, the only options available fo... 4 months ago | 58 mins 희귀 질환 대상자 모집: 갈수록 경쟁이 심화되는 연구 환경에서 등록 장애물을 해결하고 임상시험을 차별화하는 방법 Premier Research – Jackie Brown, 부사장, 희귀질환 이 웨비나에서는 유전자 치료제 개발시 국제 규제(Regulatory) 환경에 맞춰 방향을 읽는 법 및 다양한 현지 규제(Regulatory) 환경을 고려하여 성공적인 임상시험 전략을 개발하는 법에 대해 다루고자 합니다. 또한, 제품 개발 및 승인 프로세스를 간소화할 수... 4 months ago | 48 mins The Expanding Role of RWE in Rare Studies Premier Consulting – Shari Medendorp, MPH, President, and Nach Davé, RPh, MS, Vice President, Development Strategy Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting ... 4 months ago | 63 mins Establishment of a Patient-derived B-ALL Ex Vivo Platform Bandana Vishwakarma, PhD, Scientist in Hematology Oncology at Champions Oncology Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availab... 2 years ago | 23 mins Load more
