"Science Behind the Best Health"


Key Issues and Seminar Contents: Participants will see the integral module introduces the current pharmaceutical industry and provides an informative overview of the stages of developing a new pharmaceutical product - active substance discovery, research and testing measures; general procedure of drug approval application and marketing authorization. Drug development process and regulatory bodies in Canada. Each topic informs you with brief history, modern status, demands and general trends, Pharmaceutical Seminars Categories and Topics Questions to be stated, discussed and answered are following: What is considered to be a drug? How are drugs developed? From Active Substance ..- To Marketed Drug; Coffee Poisons & Venoms - are they drugs? Accidental and Aimed Discovery; Laboratory Research; Pre-Clinical Tests and Clinical Trials What is the intent and outcomes of laboratory studies and clinical trial? World Harmonization Requirements (ICH/GCP guidelines, FDA/TPD regulations). Essential Documents, Investigator Sites, Regulatory Bodies, Ethic Code and Standards What are the regulatory requirements to the registered drug? Manufacturing Process and Technologies Transfer: Quality & Compliance, Batch to Batch Stability, Microbiological Purity, Validation & Audits What are the steps in the drug authorization - application and approval process? Stages, Requirements, Outcomes How long does the drug review process take? Past & Present Status; Trends of the Nearest Future

Are the drug development and approval process in Canada differs?

Health Canada's Therapeutic Products Directorate (TPD) Guidelines

Regular Procedure & Priority Review Process. Brand Name Drugs & Generics

Is there any post- approval monitoring of a drug in Canada? Marketing Withdrawals of the Last Years What are the Pharma. Industry's current Problems; Research Technology Trends; Modern Marketing Tendencies? ...etc. All your questions will be answered in Ideal Pharmaceutical Alliance (IPA) Seminars

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