Course "Japan Regulatory Compliance Requirements for Life Science Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country. The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.
Course Objective:
Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:
The impact of the PAL to PMDL Law change to applicants
Who can legally register Life Science products in Japan
If you want to be the legal License holder, what will you need: establishment office & personnel type
When will additional clinical trials be needed on products and on which ones
Will Japan accept global, clinically-developed data
How does a Japanese CTD submission differ from ICH requirements
What is required to register a Medical Device in Japan
Japan's Medical Device classification procedures and regulatory pathways
Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines
What are your post-marketing responsibilities as a License Holder
How best to work with the Authorities from a Business and Cultural Aspect
Who will benefit:
This seminar will benefit Project Team Members, whose specific functional discipline comes from:
Clinical Operations Staff
Quality Assurance
Monitors / CRAs
Regulatory Affairs Personnel
Pharmacovigilance Reporting personnel
Global Supply Chain personnel
Manufacturing personnel
Global Business Development personnel
Commercial Management
Country Managers
CRO's, Consultants
Agenda:
Day 1 Schedule
Part I: Japan Regulatory Compliance
Lecture 1:
Japan's Regulatory Structure for the Life Science Product Industries
Country Healthcare System
Regulatory Framework: Key Agencies Involved / Reporting Structure
MHLW (Ministry of Health, Labor and Welfare)
PMDA (Pharmaceutical and Medical Device Agency)
Agency Consulting Committees
Patent System
Pharmaceutical Affairs Law (PAL) → Pharmaceuticals & Medical Device Law (PMDL)
Lecture 2:
Beginning Your Company Involvement in Japan
Local Office and Personnel Requirements
Language Requirements & Translations
License Types
Options for Importers / Overseas Manufacturers
Lecture 3:
Objectives of the Rules Governing Medicinal Procedures
Life Science Regulations and the Regulatory Processes in Japan
Conducting Clinical Trials
New Product Registrations
Handling of Risk Management
Post-Marketing Requirements: Variations / amendments, Safety Reporting, Renewals
Lecture 4:
Japan's Use of ICH Standards / Principles
GCP
GMP
CTD / e-CTD Submissions
Lecture 5:
Starting-Up and Conducting Clinical Trials
Who can conduct Clinical Trials?
When are they needed?
Start-up Process & Timelines
Day 2 Schedule
Part II:
Lecture 1:
Marketing Authorization Processes - Product Registrations / Licensing
Drugs
Medical Devices
Biologics
Combination Products
Drug / Device Master File (DMF) Use in Japan
Labeling Requirements
Packaging Information Leaflets
Lecture 2:
Variations: Changes to Marketed Products
Types of Variations & Dossier Maintenance Expectations
Lecture 3:
License Renewals
Process and timing for Renewing Licenses
Lecture 4:
Comparing and Contrasting Japan's Procedures vs. U.S. FDA
Comparison of Processes
Expected Timelines
Lecture 5:
How and When to Influence the Regulatory Process
The Do's and Don'ts of Regulatory Involvement in Japan
Utilizing Local Regulatory Resources
Speaker
Robert Russell
President / CEO , RJR Consulting, Inc.
Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.
Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
Location: Seattle, WA Date: October 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA
Price:
Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
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