Ahead of his presentation at the inaugural Extractables and Leachables China, we spoke to Dr Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions, about the Chinese regulations, how these may differ from US or European regulations, challenges faced by companies operating in the Chinese market and more.
Q1. We are now starting to see guidelines from the Chinese regulators on how regulations are going to play out in China – what are the main challenges or surprises that you foresee as companies implement these?
When one goes from an environment of less formal regulation to an environment of more formal regulation, there is always the opportunity for surprises as “what worked in the past may not work in the future”.When one works in an environment of regional (as opposed to global) regulations there is always the opportunity for “that is not the way we have to do it in the (you name the location)”.When the means for scientific discussion and debate are limited, there is always the opportunity of “I had no idea that the science says that this was the wrong way to do things”.
Q2. How do you feel that Chinese regulations might differ to US or European regulations?
Let’s be very clear here.The purpose of regulations is to ensure that pharmaceutical products are safe, effective and cost-efficient.This is equally true in all locations on the globe.Furthermore, regulations should be based on sound, documented, reproducible and practical science and the science should be the same at all locations on the globe.
Surely a pharmaceutical product that is safe in the US is also safe in Europe and in China.Surely a data-based and logically conceived scientific principle is the same principle in the US as it is in Europe and in China.
Thus, there is no compelling reason that regulations should be different, China, US, EU or anywhere else as the purpose is the same and the science is the same.
Although this is surely wishful thinking on my part, there is no place and no value in having US regulations, European regulations and China regulations.Rather, there should be global regulations.The fact that the pharmaceutical industry is a global industry clearly establishes that the most efficient regulatory model is supported by global regulations.
Q3. Why do you feel it is important to be involved in an event looking at E&L in China?
I am absolutely convinced that we are entering the “golden age of E&L” where much of the essential and “basic” science is known and available. Whether it has been shared with and accepted by scientists all over the globe has yet to be seen. This event allows us to come together as a scientific community and to share data, information, insights and concerns. The logical outcome of this is an even global playing field in terms of the science. This even playing field of science is the foundation for global regulations.
I am also absolutely convinced that standards setting organizations and organizations that seek to establish best practices have accumulated much insight and have weathered much criticism as they have completed major E&L standards and documents. This experience, science and compromise that are reflected in these documents will also be a foundation for the globalization of regulations.
As an advocate for global standards, it is imperative to be part of the discussion that is happening in China and in other locations.
Q4. What are you most looking forward to at the event?
As always, I do so look forward to the opportunity to debate science, policy, and philosophy with my talented, knowledgeable, engaged and insightful colleques and friends across the globe. I cannot wait to hear about what they are working on, what they are excited about, and what they are most frustrated with.
Dr. Jenke will be presenting as part of the 'Regulatory Landscape, Expectations and Protocol Insights' session at E&L China this September. Other presenters in the session include Dr. Cheryl Stults, Dr. Dan Norwood and more.
Representatives from SGS, GE Healthcare, Fresenius Medical Care, Saint-Gobain, Suzhou Amerigen Pharmaceutical Co., NIBRT, Beijing University of Chemical Technology, Suzhou Baxter Medical Products, Shanghai Clear Fluid Biomedical Science & Technology Co. and more have already confirmed their attendance, so how can you afford to miss out?
Book your ticket for just $1,199 now to ensure your place at China's only two-day event dedicated to extractables and leachables.
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