This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets - Brazil, Russia, India and China.
Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense.
Structured healthcare systems and insurance coverage is now more prevalent among these emerging nation populations and predictions for growth of Rx and OTC products is impressive in these relatively untapped markets.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Brazil, Russia, India and China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators review filings and registrations and what is expected in the authorization and dossier maintenance of licensed products throughout their life.
Understanding cultural norms, establishing relationships and protecting your intellectual property will also be discussed and these will need to be integrated into your company training and corporate business strategies.
Added by complianceonlinecom on January 1, 2013