Our experts will participate in the following panel discussions:
Friday, October 9, 14:00-15:00 (CET): An overview of the main regulatory issues affecting the pharmaceutical industry
Our expert, Gary Chambers, Global Head, Life Sciences at SGS will attend this panel.
With the existence of a wide variety of regulatory approaches in the different knowledge areas, it becomes a priority to encourage regulatory harmonization. As the global market becomes more critical, pharmaceutical companies will require more significant cooperation among national regulators to get life saving products to market faster and minimize issues with regulatory compliance.
- Are the current regulatory frameworks ready to support innovation?
- Balancing opportunities and challenges
- Novel regulatory pathways and approaches
- Protecting trade secrets in the medical product approval process
- Compounding: challenges for the (bio)pharmaceutical industry
- What are the major impacts of new regulations on drug manufacturing?
- How to handle changes and variations in a changing environment and a global market
- Moderator: Sarah Hardison, Head of Regulatory, Clarivate Analytics
- Aimad Torqui, Director of Global Regulatory Policy, MSD
- Chris Rojewski, Associate Director, Regulatory Affairs Lead, Pfizer CentreOne
- Gary Chambers, Global Head Life Sciences, SGS
- Hanneke Later-Nijland, Partner, Axon Life Sciences Lawyers
- Katherine Dutmer, General Counsel, Business Lawyer, Legal Project Manager, GC Legal Services
Tuesday, October 13, 14:00-15:30 (CET): Tackling Nitrosamine Contamination
Our expert, Houri Simonian, Director, Analytical Operations at SGS will join this roundtable, which will feature a high level panel discussion by industry experts, with numerous opportunities for audience interaction – polls, Q&A and breakout networking sessions. This will provide a great opportunity to deep dive into specific topics, discuss opinions and gather insights from the wider pharma community.
Medicine regulatory authorities first became aware of the presence of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in 2018. Since then, the work towards preventing and managing the presence of nitrosamine impurities in medicines has gained attention. Understanding when and where nitrosamines may become present in drug products has become a growing task for the pharmaceutical industry. A better understanding of the precursors and conditions that trigger their formation might lead the industry to reduce the possibility of nitrosamines appearing in pharmaceutical products, in order to assure the safety of patients and the quality of the final drug substance.
- Moderator: Dr. Antonio Conto, European Registered Toxicologist – Chemsafe
- Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca
- Houri Simonian, Director, Analytical Operations, SGS
For further information, please contact:
Global Marketing Manager
t: +41 22 739 91 11