China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019

China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations 2019 is a conference dedicated to this China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements.

Key Topics

• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
• The current Regulatory Structure.
• Clinical Trials: Why consider Country X? CTA requirements, the Application Process, CRO Selection and Start-up.
• How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
• Pricing establishment.
• The current key regulations effecting product development and your company`s product pipeline.
• Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China and countries from the Pacific Rim to your company`s global market presence.
• Understanding the local concerns and specific challenges in working with Local Regulatory Personnel.
• Strategies for streamlining the registration application process for faster approval.
• Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package.
• Maintenance of Authorized Products.

Who should Attend

• Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
• Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require local knowledge of regulatory, quality and import / export requirements
• Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider China & the Pacific Rim into one`s Global Business Strategy will profit from attending