China & Pacific Rim Markets: Compliance Processes for Life Science Products – Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations: 2-day In-person Seminar

By: Robert J. Russell, President of RJR Consulting, Inc
Location :- Pyramid Club Philadelphia, PA | Thursday, August 23, 2018 | Friday, August 24, 2018

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Course Description:

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.

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 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.

Course Outline

DAY 1 - China



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


  • 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.

Meet Your Instructor

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.

Venue

Location :

Pyramid Club
1735 Market Street
BNY Mellon Center - 52nd Floor
Philadelphia, PA 19103, USA
Tel: +1 215-567-6510

August 23-24, 2018



How to Reach

General Driving Directions:

Driving directions from Philadelphia International Airport - 9.2 miles:
  • Get on PA-291 E/Penrose Ave from Garage Access Rd and Exit 13.
  • Continue on PA-291 E/Penrose Ave.
  • Take S 26th St and I-76 W to N 18th St. Destination will be on the right.
Select hotels close to meeting venue:
  • 300 feet | 1 min walk | Sonesta Philadelphia Downtown Rittenhouse Square | 1800 Market St, Philadelphia, PA 19103 | sonesta.com | (215) 561-7500 | $199/night
  • 0.2 mi | 4 min walk | Hotel Sofitel Philadelphia | 120 S 17th St, Philadelphia, PA 19103 | accorhotels.com | (215) 569-8300 | $395/night
  • 0.1 mi | 3 min walk | The Westin Philadelphia | 99 South 17th Street at Liberty Place, Philadelphia, PA 19103 | westinphiladelphiahotel.com | (215) 563-1600 | $214/night

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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Seminar One Registration

August 23-24, 2018, Philadelphia, PA

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Testimonials

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

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Local Attractions of Philadelphia, PA:

Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit. Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

Valley Forge National Historical Park
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The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

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The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space. Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.