Providing assurance of the quality of the pharmaceuticals (medicines and medicinal products - both prescription and non-prescription) to the patients/consumers is one of the main objectives, as well as mandates, of the regulatory authorities and the manufactures. The regulatory authorities develop and set the standards based on available scientific knowledge and then later monitor adherence ("compliance") to them. On the other hand, manufacturers manufacture the products based on these regulatory standards (quality standards or "goalposts") by meeting or exceeding the required standards.
The focus of the seminar is to provide a concise overview of the scientific basis of quality assessment and requirements of meeting regulatory compliance requirements. Current challenges facing the industry in this regard will be highlighted, with suggestions to address them, will be described in detail.
This seminar should be a must to attend for anyone involved in product development and manufacturing, quality control/assurance and regulatory compliance aspects.
Why you should attend
Attendees will learn about scientific concepts of quality of pharmaceuticals (medicines) and pharmaceutical (medicinal) products. How quality is assessed and established based on clinical (bio-, in vivo) and/or in vitro approaches. Details of analytical methodologies required will be provided as per regulatory compliance guidance documents. Current challenges and suggestion for addressing these will be explained.
It would be an unmatched opportunity to learn from an internationally recognized leader of the subject. A must attend seminar for anyone involved in product developments and assessments of solid oral dosage forms!
Who Will Benefit
Anyone working as bench chemist/analyst, supervisor, managers, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, in the following areas:
- Pharmaceutical Development
- Setting up analytical methods (pharmacopeial, regulatory or in-house developed)
- R & D, both analytical and formulation
- Project Management
- Quality Control
- Quality Assurance
- Regulatory Affairs
- Concept of quality - in general
- Definition of quality pharmaceuticals and measurable parameters
- Techniques for assessing quality of pharmaceutical products
- Clinical (in vivo/bio) methods (bioavailability/bioequivalence assessments) A typical study protocol with regulatory requirements
- In vitro methods (drug release/dissolution approach) – developing and using methods
- Making choices between the techniques
- Relevant analytical techniques (e.g. chromatography)
- Challenges and solutions
- Validation, or lack, of:
- currently suggested quality assessment approaches
- Suggestions to address them
Dr. Saeed Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. His areas of expertise include: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.
Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.
Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).