PharmaLex Talks
By PharmaLex Talks
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Category: Life Sciences
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Episodes: 29
Description
Hosted by PharmaLex and with guests comprised of leading industry figures, the PharmaLex Talks podcast is a place for discussion on important topics within the Pharmaceutical and Pharma-adjacent sectors.
| Episode | Date |
|---|---|
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29: Exploring the interactions between validation and technology transfer
|
Jan 24, 2024 |
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28: Early access programs: What they are and how to plan for them
|
Dec 05, 2023 |
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27: Assessing gaps and achieving compliance with Annex 1
|
Nov 28, 2023 |
|
26: Navigating the Process of Technology Transfer
|
Nov 14, 2023 |
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25: Scaling Patient Safety through Innovation
|
Sep 25, 2023 |
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24: Why Early Phase Modeling is Key to Reimbursement and Patient Access
|
Sep 12, 2023 |
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23: The Unique and Complex World of Combination Products
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Aug 31, 2023 |
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22: Avoiding Pitfalls with your Product Development Strategy
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Aug 02, 2023 |
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21: Navigating a complex global regulatory environment to bring medicinal products to market
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Jul 18, 2023 |
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20: Safety Reporting Requirements for Marketing in the EU
|
Jul 06, 2023 |
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19: The important role of AI in TMF oversight
|
May 24, 2023 |
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18: Tackling performance requirements in the more prescriptive world of IVDR
|
Apr 05, 2023 |
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17: Gaining efficiencies with custom statistical solutions in a GxP setting
|
Mar 15, 2023 |
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16: How the quality culture impacts GMP activity
|
Feb 22, 2023 |
|
15: Managing the medical device pre-submission process with the FDA
|
Jan 17, 2023 |
|
14: Digitalization as a tool in the outsourcing journey
|
Jan 09, 2023 |
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13: Improving efficiency and mitigating risk through strategic product development
|
Dec 05, 2022 |
|
12: Bayesian and ICHQ2 and Q14
|
Oct 06, 2022 |
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11: How Bayesian thinking addresses complex issues with clinical studies
|
Sep 08, 2022 |
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10: How the MDR has changed the roles and responsibilities of “economic operators”
|
Aug 08, 2022 |
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9: The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance
|
Jul 06, 2022 |
|
8: Solving the Innovation Dilemma with Integrated Product Development
|
Jun 01, 2022 |
|
7: How software is changing the use of and types of medical devices
|
May 13, 2022 |
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6: Annex 1 – Are you ready for implementation of the new Annex?
|
Apr 06, 2022 |
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5: Getting Ready for the IVDR
|
Mar 11, 2022 |
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4: The Why, How, When and What of EU MDR Regulation
|
Feb 04, 2022 |
|
3: Bayesian Statistics
|
Nov 29, 2021 |
|
2: Challenges & Regulatory landscape for ATMPs
|
Nov 15, 2021 |
|
1: Post Brexit landscape for the pharmaceutical industry
|
Sep 06, 2021 |