ComplianceOnline

China Regulatory Compliance for Life Science products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

Instructor: Robert J Russell
Product ID: 702037
  • 7
  • June 2017
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min

Live Online Training
June 07, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$199.00
One Dial-in One Attendee
$449.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 90-minute China life science compliance based webinar will discuss the regulatory structure and requirements for compliance with Chinese SFDA 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.


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Learning Objectives:

This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle 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? SFDA'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.

Areas Covered in the Webinar:

  • 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.
  • Reimbursement.
  • 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.
  • Conclusions.

Who Will Benefit:

This course will be beneficial to:

  • Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of China's regulatory, quality and import / export requirements
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant
  • 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 into one's Global Business Strategy will profit from attending
Instructor Profile:
Robert J Russell

Robert J Russell
President, RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

Topic Background:

The Chinese government's establishment of a single drug regulatory authority in 2003 (China Food and Drug Administration) was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent to industry partners. The CFDA now oversees all medications. Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. The Ministry of Health retains its other main functions: regulatory development and oversight, healthcare resource allocation, and medical research and education.

  • Along with it in 2010, China has amended GMP, GLP, GCP, GSP and other regulations, China‚Äôs aim is to further align the country with international standards of practice. For manufacturers and distributors and importers of drugs and medical devices in China, it is imperative to pay close attention to the pace at which CFDA implements these changes. They have to make changes accordingly to their standard operating procedures, so that they can ensure compliance quickly and effectively with the evolving regime.
  • China [CFDA] continues to make Regulatory Requirement Changes at a fast pace. Just in the last couple of years alone, changes have been proposed and implemented in Drug & Biologics Licensing, Medical Device Registrations and have been proposed for Dietary Supplements approved by CFDA. This 90-minute webinar will update you with all of these changes.
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

Appreciated that the topic was approached to broadly and especially that the presenter added "Culture" to the agenda.
- Klaus Goodwin

I was very happy with the content of this webinar. It listed the regulations and key points to consider and compared them to what we typically do in the US/ EU.
- Wendy H Severs

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