Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
Interview with Robert Zoubek
Read the interview with our expert trainer Robert Zoubek about the CMC Courses.
1. This was your 4th CMC Training with Fleming - Do you remember any funny story from them? Or a funny question asked by a delegate or maybe something extraordinary happening...?
I´m German. I really wonder how you came to this question? ;-)
2. Do you see any changes in our CMC Courses since the 1st one in terms of delegates, questions...?
Yes, definitively. In the beginning, the concept of how to develop was still not very much known to the audience, thus not only the content but also the questions were mainly covering very general aspects. In the meantime, this has changed. The course content now discusses very specific pitfalls during biosimilar development and the course leaders give particular examples of how to deal with them. One can clearly see that the audience themselves already have significant experience in Biosimilar development. This can be also observed from the contribution of the participants to the course. There is much more in-depth discussion going on now than there was four years ago … and that's great!
3. Did you also learn something new at these trainings? (During panel discussions with delegates or at networking coffee breaks?)
Constantly. There are not only participants from the industry – wholesalers and service providers – but also from regulatory agencies. I love these opportunities to connect with them either during the sessions or during the breaks to learn about their most recent difficulties, trends and opinions. I always try to engage them and their knowledge in our sessions so that everyone can learn from each other and that problems generally common to the industry can be openly discussed.
4. Do you plan to implement something new in the next editions of CMC Training? New topics or new event format?
I always try to evolve the content of the course based on the most recent developments and the feedback from industry and regulators. For the next course, it's time to move away from the general regulations of Biosimilars towards the very specific requirements for analytical comparability. I will introduce new as well as proven concepts based on my experience with US and EU regulators.
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Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.