3-hr Virtual Seminar - China: Compliance Processes for Life Science Products
Wednesday, August 7, 2013 from 10:00 AM to 1:00 PM (PDT)
This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
Why Should You Attend:
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which CFDA implements these changes and makes additional changes to their operating procedures when forming the nation-wide Agency in 2013.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the CFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the life-cycle of Life Science Products (pharmaceuticals, medical devices, biologics, combination products) as an importer into China. It will provide training on:
- The Regulatory Structure in China.
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
- How to begin your company’s involvement in China: local licenses, personnel and facilities required.
- Clinical Trials: Why China? CFDA’s requirements, the Application Process, CRO Selection and Start-up.
- The current key regulations effecting product development and your company’s product pipeline.
- Pricing establishment.
- Understanding the local concerns and specific challenges in working with Chinese Regulatory Personnel.
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China to your company’s global market presence.
- Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package.
- Strategies for streamlining the registration application process for faster approval.
- Maintenance of Authorized Products: Variations & Amendments to Licenses
Areas Covered in the Seminar:
- Country Profile / Healthcare System.
- Key Country Information.
- Strategic Considerations: Why China? / Asia Structure / Hub Locations.
- Governmental & Regulatory Authorities / Agencies / Structure.
- Company Establishment; Licenses & Key Personnel.
- Partner Companies / Local Relationship Options.
- In-Country Operational Considerations; Importance of Local Distributors
- Requirements to Conduct Clinical trials / Approvals / GCP
- Licensing Products ( Innovative Drugs , Generics / Similars, Orphan Drugs, Biologics / Vaccines, Medical Devices).
- Variations and Amendments to Licenses.
- GMP and Inspections.
- Packaging and Labeling.
- Price Establishment.
- Import / Export / Customs Clearance.
- Taxes / Duties.
- Advertising & Promotion.
- Vigilance Reporting / Post-Marketing Requirements.
- Patents & Trademarks.
- Local Customs / Cultural Issues / Establishing Business Relationships.
- Working with Local Agencies / Authorities.
Note: A detailed, 6-hr training is available on the same topic. Email CustomerCare@complianceonline.com for more information on the training CD.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.