IPA Canada: Professional Pharmaceutical Training

Pharmaceutical

Key Issues and Seminar Contents

Participant 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

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., etc

Solutions of Ideal Pharmaceutical Alliance (IPA)

Professional Pharmaceutical Seminars will provide you:

· Up-to-date systemic professional knowledge of a remedy development process, tracing it from research laboratory to pharmacy shelf

· Drug application and review by regulatory bodies: approval process, stages – general harmonized guidelines and Canadian specifics

· Strategic picture of modern pharmaceutical industry: history, current status, visible trends and following expected challenges

· Skills required by the modern industry and permanent learning demand

· Open mind to make timely and competent decisions

Optimization of regular business performance to get both:

Effectiveness and revenue to your company
Individual career development to you