What analytical data is required in order to be granted permission for a clinical trial or commercial distribution?
Morton Grove, IL (PRWEB) May 28, 2015
Regis Technologies will host a technical talk in Cambridge, MA delivered by their Director of Analytical Method Development, Paul Wrezel, Ph.D. The talk is free and open to the public. Arrive at 8:00am for coffee and networking; the seminar will begin at 8:30am and will last one hour.
"Analytical Strategies for Drug Development" will cover analytical method development for pharmaceutical drug substances, or small molecule, active pharmaceutical ingredients.
Dr. Wrezel will answer important questions, such as:
- What analytical data is required in order to be granted permission for a clinical trial or commercial distribution?
- What kind of methods are needed?
He will also overview regulatory requirements and their path as the program moves towards commercial. The challenge is in knowing these requirements for each stage of the candidate drug evolution, for instance, what is necessary to support a Phase-1 IND or a generic ANDA. Regulatory agencies like the FDA and EMEA, compendial sources such as the US and European pharmacopeias, and harmonization efforts like ICH provide guidances at steps along the path. Dr. Wrezel will also provide industry best practices from the perspective of a contract manufacturing organization on this phase of pharmaceutical drug development.
More information, including the abstract and how to register, is available on the Analytical Method Strategies for Drug Development home page.
Dr. Paul Wrezel has worked in the pharmaceutical industry for over 20 years. He received his undergraduate degree in chemistry from Loyola University of Chicago and his Ph.D. in biochemistry from Northwestern University. Prior to joining Regis Technologies, Paul worked for both Searle/Pharmacia and Kraft General Foods. Paul has a diverse background with deep experience in biochemistry, microbiology, food science, and analytical chemistry. Within the pharmaceutical industry, he has developed dosage form methods, managed a toxicology pre-formulation group, and served as a multi-functional project team leader for drug candidates in clinical development.
Paul has worked for Regis as the Director of Analytical Method Development since 2003. He is responsible for leading the Regis Analytical Team with oversight on method development, validation, stability, quality control, and pharma services. While with Regis, Paul has formed the method development/validation department, which in turn has published in peer-reviewed journals such as LCGC North America.
Regis Technologies hosts technical seminars at its Morton Grove, IL location and around the country throughout the year. This summer, Regis will also host a live seminar on process development in San Diego (June 11th) and a webinar on the IND process (date TBD).