התחל במצב לא מקוון עם האפליקציה Player FM !
פודקאסטים ששווה להאזין
בחסות


173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
Manage episode 463710092 series 3325357
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️
Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/
Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.
In this episode of Let's Combinate, host Subhi Saadeh interviews Shelley Amster, a trailblazer in reproductive health with over 45 years of experience.
Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelley also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements.00:00 Welcome to Let's Combinate00:13 Pioneering in Reproductive Health00:42 Early Challenges and Opportunities02:10 Breaking Barriers in IVF04:52 Career Reflections and Lessons06:40 Conference Planning Insights13:37 Overcoming Shyness and Networking19:11 Retirement and Career Advice26:21 Innovations in Women's Health30:26 Future Technologies and Closing ThoughtsShelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women’s health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
179 פרקים
Manage episode 463710092 series 3325357
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️
Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/
Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.
In this episode of Let's Combinate, host Subhi Saadeh interviews Shelley Amster, a trailblazer in reproductive health with over 45 years of experience.
Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelley also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements.00:00 Welcome to Let's Combinate00:13 Pioneering in Reproductive Health00:42 Early Challenges and Opportunities02:10 Breaking Barriers in IVF04:52 Career Reflections and Lessons06:40 Conference Planning Insights13:37 Overcoming Shyness and Networking19:11 Retirement and Career Advice26:21 Innovations in Women's Health30:26 Future Technologies and Closing ThoughtsShelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women’s health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
179 פרקים
כל הפרקים
×
1 176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski 26:20

1 175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau 39:49

1 174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin 23:57

1 173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's 32:58

1 172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead 34:19

1 171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products? 7:59


1 169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective 16:36

1 168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth 13:21

1 167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst 41:13

1 166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success 20:51

1 165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New 1:10:41

1 164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790 13:15

1 163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle 11:19

1 162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them) 17:43
ברוכים הבאים אל Player FM!
Player FM סורק את האינטרנט עבור פודקאסטים באיכות גבוהה בשבילכם כדי שתהנו מהם כרגע. זה יישום הפודקאסט הטוב ביותר והוא עובד על אנדרואיד, iPhone ואינטרנט. הירשמו לסנכרון מנויים במכשירים שונים.