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					 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




                                         DESCRIPTION


                                         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
                                         Combination Products.

                                         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
                                         products.
Pricing

                                         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
                                                      Personnel.
                                                      ·Partner Companies / Local Relationship Options.
This course will be beneficial to:
                                                      ·In-Country Operational Considerations;
                                                      Importance of Local
·Regulatory,    Quality,   Manufacturing,
                                                      Distributors
Global Business
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,
                                                      Medical Devices).

· 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.
                                                      ·Reimbursement.
·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
                                                      Business Relationships.
                                                      ·Working with Local Agencies / Authorities.
                                                      ·Conclusions.

                                            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.

Topic Background:


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.
About Speaker

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.
https://compliance2go.com/index.php?option=com_training&speakerkey=11&productKey=51

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