ComplianceOnline

This China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements for compliance with in-country regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

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 SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.

Other Pacific Rim markets are also growing in importance and interest in access to innovative products. In-country Regulatory Agencies are progressing in their sophistication, process development and regulatory requirements.

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries* (Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand). The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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 & the Pacific Rim. It will provide training on:

  • The current Regulatory Structure.
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
  • How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
  • Clinical Trials: Why consider Country X? CTA 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 Local Regulatory Personnel.
  • 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.
  • 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.

Who will Benefit:

This course will be beneficial to the following personnel whose responsibilities require knowledge of these Emerging Markets' regulatory requirements for Life Science products:

  • Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require local knowledge of 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 & the Pacific Rim into one's Global Business Strategy will profit from attending

Topic Back Ground:

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.

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DAY 1 - China(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Country Profile / Healthcare System.
  • Key Country Information.
  • Strategic Considerations: Why focus on this country? / 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.
DAY 2 - A high-level review of following topics for Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand(8:30 AM - 4:30 PM)
  • Country Profile / Healthcare System.
  • Key Country Information.
  • Strategic Considerations: Why focus on this country? / 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.
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Robert J. Russell

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.

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Register Now

Online using Credit card

$1,499.00

Seminar One Registration

January 24-25, 2019, San Francisco, CA
(Registrations till December 19, 2018 - $1499)
(Registrations After December 19, 2018 - $1699)




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    San Francisco, CA
    (Venue to be announced shortly)

    January 24-25, 2019

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Testimonials

    See What People Say About Us

    Bob was a great instructor, very helpful. Thanks to ComplianceOnline.com for conducting this seminar, Medical Device companies always need to be compliant so guidance/updates are always needed. I would recommend ComplianceOnline.com to others. Thanks!

    Manager, Clinical Operations

    This seminar had great overview and introduction to Japan & S. Korea regulatory and clinical environment. Medical Device related material was most valuable for me as it is most aligned with my work. The amount of interaction between the participants and presenter was ideal. I would like to attend future seminar on "Regulatory and Clinical for Latin American countries".

    Director of Global Product Safety

    Understanding the regulatory structure in the countries and how they interact, was the most valuable topic for me. Overall it was a good seminar - I learned a lot. Enjoyed the informal nature and being able to ask questions as went along. I would like to give thanks to ComplianceOnline for good customer service on the phone.

    Clinical Project Manager, Global Clinical Affairs

    Overall it was a good course for Japan/S. Korea familiarity. More content on device, more discussion using application of data in real life scenarios, and less straight reading slides. I would like to attend future conferences on "Medical Device Tech Files" and "Medical Device Directives & Essential Requirements".

    Regulatory Affairs Specialist

    ComplianceOnline website was helpful and informative for the conference. I like the areas covered on "Identification of regional differences, and regulations & processes". subject was well chosen and overall it was good experience.

    Sr. Director, Gilead

    This course was offered by ComplianceOnline and it was excellent. Bob is very knowledgeable and have answered all my questions. I like the knowledge delivered on Clinical, however, got a lot more on other topics as well. Good Summary. I would like to attend future seminars on China and Latin America.

    Sr. Director of Regulatory Affairs

    Instructor was very knowledgeable on topic. Length of the program was appropriate. I like the session of overall submission process. I would like to attend future seminars on China & Asia, and BRIC.

    Regulatory Affairs Specialist

    The company is very professional and the presenter is a seasoned regulatory expert. I feel the information delivered was accurate and advice will streamline registrations for my company globally.

    Sr. International Regulatory Affairs Specialist, Church & Dwight Co, Inc

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

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