13: Improving efficiency and mitigating risk through strategic product development
This podcast introduces the concept of strategic product development as part of an integrated strategy to bring new drugs to the patients that need them. This holistic approach helps to save time, red...
5 Des 202212min
12: Bayesian and ICHQ2 and Q14
Introduction: The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But...
6 Okt 202217min
11: How Bayesian thinking addresses complex issues with clinical studies
Brad Carlin is a statistical researcher, methodologist, consultant, and instructor. He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical...
8 Sep 202215min
10: How the MDR has changed the roles and responsibilities of “economic operators”
Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these res...
8 Aug 202213min
9: The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance
The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature produc...
6 Jul 202215min
8: Solving the Innovation Dilemma with Integrated Product Development
A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market. To find out mo...
1 Jun 202211min
7: How software is changing the use of and types of medical devices
Classification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores softw...
13 Mai 202213min
6: Annex 1 – Are you ready for implementation of the new Annex?
Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.
6 Apr 202216min
