Live Webinar on: China: Compliance Processes for Life Science Products (Company
Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
Tuesday, August 21, 2012 duration : 01:00 to 02:30 PM EDT
This 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
Why Should You Attend
Get 15 % Discount as a early bird China has been improving its regulatory regime governing the food
registrations. Use Promo Key : and pharmaceutical industry in recent years. In 2010, by promulgating
CGO15 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 SFDA implements these changes and to make changes
to their standard operating procedures when necessary to ensure
compliance with the evolving regime.
This course specifically focuses on the overall overview of 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 SFDA process filings and registrations and what is
expected in the authorization and dossier maintenance of licensed
Areas Covered in the Seminar :
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $449 · Country Profile / Healthcare System.
Play Back - Unlimited views $319 · Key Country Information.
· Strategic Considerations: Why China? / Asia
Structure / Hub Locations.
·Governmental & Regulatory Authorities /
Agencies / Structure.
Who will benefit ·Company Establishment; Licenses & Key
·Partner Companies / Local Relationship Options.
This course will be beneficial to:
·In-Country Operational Considerations;
Importance of Local
·Regulatory, Quality, Manufacturing,
Development and General Management ·Requirements to Conduct Clinical trials /
Approvals / GCP
personnel whose responsibilities require
knowledge of China's regulatory, quality ·Licensing Products ( Innovative Drugs , Generics
and import / export requirements / Similar, Orphan Drugs, Biologics / Vaccines,
· Administrative staff responsible for ·Variations and Amendments to Licenses.
ensuring compliance with regulatory ·GMP and Inspections.
filings and overall GCP, GMP and GLP
·Packaging and Labeling.
compliance requirements will also find
this training highly relevant ·Price Establishment.
·Global business development and
·Import / Export / Customs Clearance.
general management requiring an
understanding of how regulations and ·Taxes / Duties.
compliance issues are culturally handled ·Advertising & Promotion.
along with how best to consider China
·Vigilance Reporting / Post-Marketing
into one's Global Business Strategy will Requirements.
profit from attending
·Patents & Trademarks.
·Local Customs / Cultural Issues / Establishing
·Working with Local Agencies / Authorities.
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.
·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
·Information necessary for effective dossier preparation; or how does
one take an already approved dossier and turn it into an acceptable
· Strategies for streamlining the registration application process for
·Maintenance of Authorized Products.
The Chinese government's establishment of a single drug regulatory
authority in 2003 (The State 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 SFDA 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's 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 SFDA 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.
Robert J. Russell is President and CEO of RJR Consulting, Inc, a
leading Global Regulatory Consulting firm focusing on assisting the Life
Science Industry. Prior to founding the firm in 2000, Mr. Russell had
over 27 years of experience in CMC, Global Business Development and
Regulatory Compliance for pharmaceuticals, biologics, medical devices
and combination products. The company has an office in Brussels,
Belgium where they interact with the European Commission and the
Competent Authorities across the EU. Country establishment,
marketing authorizations, variations and license renewals are core
competencies of the course director. Mr. Russell has received a B.S.
and M.S.in Chemistry.
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