4-hr Virtual Seminar - Japan: Regulatory Compliance Requirements for Life Science Products

Why Should You Attend:

This 4-hr training will provide valuable insights into how regulations and compliance issues are culturally handled in Japan.

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the MHLW / PMDA 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 Japan. It will provide training on:

• The Regulatory Structure in Japan.
• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
• How to begin your company's involvement in Japan: local licenses, personnel and facilities required?
• Clinical Trials: Why Japan? PMDA'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 Japanese Regulatory Personnel.
• Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding Japan 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.

Course Agenda:

Japan's Regulatory Structure for the Life Science Product Industries

• Demographic
• Regulatory framework: key agencies involved / reporting structure
• MHLW (Ministry of Health, Labor and Welfare)
• PMDA (Pharmaceutical and Medical Device Agency)
• PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
• Patents

Beginning Your Company Involvement in Japan

• Local office and personnel requirements
• Language requirements
• License types
• Overseas manufacturers

Objectives of the Rules Governing Medicinal Procedures

• Market authorization holder overview

Life Science Regulations and the Regulatory Processes in Japan

• Pre-clinical
• Conducting clinical trials
• New product registrations & filings
• Adverse drug reactions
• Post-marketing requirements
• Maintenance of licensed products
• Reimbursement, audits
• Risk management

Japan's Use of ICH Standards/Principles

• GCP
• GMP
• Quality documents and standards
• CTD / e-CTD submissions

Starting-Up and Conducting Clinical Trials

• Approvals
• CRO Concept in Japan
• Clinical Trials vs. Clinical Investigations

Marketing Authorization Processes – Filings & Registrations

• Drug - Pharmaceutical Affairs Law (PAL)
• Medical device
• Biologic
• Combination product
• Drug master file (DMF) use in Japan
• Similar products & devices
• Use of expert reports
• Labeling requirements
• PIL

Variations: Changes to Marketed Products

• Types of variations
• Dossier maintenance expectations
• Changes concerning manufacturing aspects (product & process)
• Labeling & packaging leaflet requirements

Renewals

Comparing and Contrasting Japan's Procedures vs. U.S. FDA

• Comparison of processes
• Agency interactions
• Accepted practices

How and When to Influence the Regulatory Process

• Japanese methods
• Cultural issues
• Effective monitoring activity
• Association vs. Individual company involvement & intervention
• The regulatory negotiation process
• Effective approaches
• The do's and don'ts of regulatory involvement

Who Will Benefit:

This course will be beneficial to the following personnel in Pharmaceuticals, Medical Devices, Biologics and Combination Products manufacturing companies:

• Regulatory Affairs Professionals
• QA/ QC
• Manufacturing/ Production
• Global Business Development
• Senior Management

This training will benefit personnel whose responsibilities require knowledge of Japan’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 Japan into one’s Global Business Strategy will profit from attending.

Instructor Profile:

Mr. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Consumer Products and Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in Product Development, Global Business Development and Regulatory Compliance for pharmaceuticals, medical devices, consumer products, food and cosmetics manufacturers. The company has offices in Columbus, Ohio, Brussels, Belgium and Buenos Aires, Argentina and several satellite offices in the Asia / Pacific region where they interact with the global Ministries of Health and product Registration Agencies. Country establishment, product licensing and maintenance and license renewals are core competencies of our speaker. Mr. Russell has received a B.S. and M.S.in Chemistry.

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