Recent Episodes
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35: Challenges and best practices for managing local pharmacovigilance activities
May 9, 2025 – 12:11 -
34: Environmental Risk Assessment and its growing importance in the German Pharma Strategy
Apr 14, 2025 – 20:31 -
33: Finding the best approach to manage sterility assurance
Jan 27, 2025 – 15:02 -
32: Commercialization Readiness
Nov 4, 2024 – 13:10 -
31: Key Steps for Site Inspection Readiness
Jun 27, 2024 – 17:45 -
30: CSS Overview
May 9, 2024 – 14:42 -
29: Exploring the interactions between validation and technology transfer
Jan 24, 2024 – 13:28 -
28: Early access programs: What they are and how to plan for them
Dec 5, 2023 – 15:21 -
27: Assessing gaps and achieving compliance with Annex 1
Nov 28, 2023 – 15:39 -
26: Navigating the Process of Technology Transfer
Nov 14, 2023 – 18:29 -
25: Scaling Patient Safety through Innovation
Sep 25, 2023 – 16:38 -
24: Why Early Phase Modeling is Key to Reimbursement and Patient Access
Sep 12, 2023 – 11:46 -
23: The Unique and Complex World of Combination Products
Aug 31, 2023 – 10:28 -
22: Avoiding Pitfalls with your Product Development Strategy
Aug 2, 2023 – 12:40 -
21: Navigating a complex global regulatory environment to bring medicinal products to market
Jul 18, 2023 – 13:53 -
20: Safety Reporting Requirements for Marketing in the EU
Jul 6, 2023 – 20:11 -
19: The important role of AI in TMF oversight
May 24, 2023 – 12:06 -
18: Tackling performance requirements in the more prescriptive world of IVDR
Apr 5, 2023 – 13:22 -
17: Gaining efficiencies with custom statistical solutions in a GxP setting
Mar 15, 2023 – 13:57 -
16: How the quality culture impacts GMP activity
Feb 22, 2023 – 21:31 -
15: Managing the medical device pre-submission process with the FDA
Jan 17, 2023 – 14:01 -
14: Digitalization as a tool in the outsourcing journey
Jan 9, 2023 – 12:12 -
13: Improving efficiency and mitigating risk through strategic product development
Dec 5, 2022 – 12:05 -
12: Bayesian and ICHQ2 and Q14
Oct 6, 2022 – 17:32 -
11: How Bayesian thinking addresses complex issues with clinical studies
Sep 8, 2022 – 15:11 -
10: How the MDR has changed the roles and responsibilities of “economic operators”
Aug 8, 2022 – 13:22 -
9: The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance
Jul 6, 2022 – 15:35 -
8: Solving the Innovation Dilemma with Integrated Product Development
Jun 1, 2022 – 11:56 -
7: How software is changing the use of and types of medical devices
May 13, 2022 – 13:43 -
6: Annex 1 – Are you ready for implementation of the new Annex?
Apr 6, 2022 – 16:40 -
5: Getting Ready for the IVDR
Mar 11, 2022 – 14:06 -
4: The Why, How, When and What of EU MDR Regulation
Feb 4, 2022 – 15:33 -
3: Bayesian Statistics
Nov 29, 2021 – 32:36 -
2: Challenges & Regulatory landscape for ATMPs
Nov 15, 2021 – 17:56 -
1: Post Brexit landscape for the pharmaceutical industry
Sep 6, 2021 – 14:07
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