Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GCPanel

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GCPanel

Overview: 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 corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution.

Agenda for Part I:

Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products Japan's Regulatory Structure for the Life Science Product Industries

Demographic Overview

Regulatory Framework: Key Agencies Involved / Reporting Structure

Recent Changes to MHLW / PMDA to Speed Review MHLW (Ministry of Health, Labour and Welfare)

PMDA (Pharmaceutical and Medical Device Agency)

PAFSC (Pharmaceutical Affairs and Food Sanitation Council)

Patents and Trademark Considerations

Beginning Your Company Involvement in Japan

Local Office and Personnel Requirement Options

Language Requirements

Possible License Types

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

Post-Marketing Requirements

Pricing & Reimbursement

Japan's Use of ICH Standards / Principles

GCP

GMP

CTD / e-CTD Submissions

Starting-Up and Conducting Clinical Trials Clinical Trial Start-Up process Japan's Effort to Reduce "The Drug Lag"

Japan's Desire to Eliminate Bridging Studies and Participate in Ph. III Global Trials

Agenda for Part II:

Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products Marketing Authorization Processes Filings & Registrations

Pharmaceutical Affairs Law (PAL) & Drug Registration

Medical Devices

Biologic Considerations

Developing Combination Products; Classification and Licensing Review

Drug Master File (DMF) Use in Japan

Labeling Requirements

Package Insert Requirements

Variations: Changes to Marketed Products

Types of Variations

Variation Filings and Typical Review Times

License Renewals

Japan's Process; What has recently changed

License Terms

Maintenance Responsibilities

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 Way of Thinking / Coming to Agreement

Important Cultural Issues for Consideration

The Do's and Don'ts of Regulatory Involvement in Japan

How to Use Regulations / Regulatory Contacts to Your Advantage Agency Interactions

Business Impact Within and Outside of Japan

Professionalism in Regulatory Affairs

Who Will Benefit: This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one's Business Strategy.

Regulatory personnel whose responsibilities require knowledge of Japan's regulatory environment.

Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.

Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.

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