BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T165305Z
UID:03486175-e58b-4bf7-b471-bd7337862b29
DTSTART:20210608T090000
DTEND:20210609T090000
CLASS:PRIVATE
DESCRIPTION:
This 2-Day seminar covers the details of the Regulatory Requ
irements for a wide-range of Life Science products in Japan: Pharmaceutica
ls\, Biologics\, Medical Devices and Combination Products. The syllabus al
so covers the change in Japan caused by the re-write of the Pharmaceutical
Affairs Law [PAL] into the Pharmaceuticals &\; Medical Device Law [PMD
L] and the country'\;s latest update to GMP requirements.
\n\nThe
information presented will help you gain a comprehensive understanding of
the Regulatory Structure\, Product Classification\, Clinical Trial Requir
ements\, Marketing Authorization Procedures\, Variations Processing\, Lice
nse Renewals\, GMP requirements and cultural working aspects within the Re
gulatory Environment in Japan. It will prepare you for regulatory approval
processes\, Agency meetings\, the complexities of running clinical studie
s\, the importance of partner selection and also add the cultural knowledg
e needed for success in-country. The recent changes made by PMDA to be mor
e sponsor and applicant-friendly\, along with the impact this has had on d
ossier review times\, will be shared. Real world experiences on actual int
eractions with the Agency\, since these changes have been implemented\, wi
ll also be discussed.
\n\n
\nCourse Objective:
\nAttendees
will leave this Course clearly understanding the Regulatory Procedures ne
cessary to be successful in getting your products to market in a timely fa
shion. This Course has been updated to provide participants with competiti
ve insight into:\n\n\n - The impact of the PAL to PMDL Law change to
applicants
\n - Who can legally register Life Science products in J
apan
\n - If you want to be the legal License holder\, what will you
need: establishment office &\; personnel type
\n - When will add
itional clinical trials be needed on products and on which ones
\n - Will Japan accept global\, clinically-developed data
\n - How does
a Japanese CTD submission differ from ICH requirements
\n - What is
required to register a Medical Device in Japan
\n - Japan'\;s Med
ical Device classification procedures and regulatory pathways
\n - C
an you expect a GMP inspection of your facility by PMDA staff\; updates to
GMP Regulation &\; Guidelines
\n - What are your post-marketing
responsibilities as a License Holder
\n - How best to work with the
Authorities from a Business and Cultural Aspect
\n
\n\n
\nWho will benefit:
\nThis seminar will benefit Project Team Members\,
whose specific functional discipline comes from:\n\n\n - Clinical Op
erations Staff
\n - Quality Assurance
\n - Monitors / CRAs
\n - Regulatory Affairs Personnel
\n - Pharmacovigilance Reportin
g personnel
\n - Global Supply Chain personnel
\n - Manufactur
ing personnel
\n - Global Business Development personnel
\n -
Commercial Management
\n - Country Managers
\n - CRO'\;s\,
Consultants
\n
\n\nDay 1 Schedule
\n\n
Part I: Jap
an Regulatory Compliance\n\n
Lecture 1:\nJapan'\;s
Regulatory Structure for the Life Science Product Industries
\
n\n\n - Country Healthcare System
\n - Regulatory Framework: K
ey Agencies Involved / Reporting Structure\n
\n - MHLW (Ministry of
Health\, Labor and Welfare)
\n - PMDA (Pharmaceutical and Medical
Device Agency)
\n - Agency Consulting Committees
\n
\n \n - Patent System
\n - Pharmaceutical Affairs Law (PAL) &rarr\;
Pharmaceuticals &\; Medical Device Law (PMDL)
\n
\n\n
Lec
ture 2:\nBeginning Your Company Involvement in Japan
p>\n\n
\n - Local Office and Personnel Requirements
\n - Langua
ge Requirements &\; Translations
\n - License Types
\n - Op
tions for Importers / Overseas Manufacturers
\n
\n\n
Lecture
3:\nObjectives of the Rules Governing Medicinal Procedures
\nLife Science Regulations and the Regulatory Processes in Japa
n\n\n\n - Conducting Clinical Trials
\n - New Product Regi
strations
\n - Handling of Risk Management
\n - Post-Marketing
Requirements: Variations / amendments\, Safety Reporting\, Renewals
\
n
\n\n
Lecture 4:\nJapan'\;s Use of ICH Standards /
Principles
\n\n\n - GCP
\n - GMP
\n - CTD /
e-CTD Submissions
\n
\n\n
Lecture 5:\nStarting-Up
and Conducting Clinical Trials
\n\n\n - Who can conduct
Clinical Trials?
\n - When are they needed?
\n - Start-up Pro
cess &\; Timelines
\n
\n\nDay 2 Schedule
\n\n
P
art II:\n\n
Lecture 1:\nMarketing Authorization Proces
ses - Product Registrations / Licensing
\n\n\n - Drugs
li>\n
- Medical Devices
\n - Biologics
\n - Combination Prod
ucts
\n - Drug / Device Master File (DMF) Use in Japan
\n - La
beling Requirements
\n - Packaging Information Leaflets
\n
\
n\n
Lecture 2:\nVariations: Changes to Marketed Products
strong>
\n\n\n - Types of Variations &\; Dossier Maintenance E
xpectations
\n
\n\n
Lecture 3:\nLicense Renewals
strong>
\n\n\n - Process and timing for Renewing Licenses
\n<
/ul>\n\n
Lecture 4:\nComparing and Contrasting Japan'\;
s Procedures vs. U.S. FDA
\n\n\n - Comparison of Process
es
\n - Expected Timelines
\n
\n\n
Lecture 5:\nHow and When to Influence the Regulatory Process
\n\n\n
- The Do'\;s and Don'\;ts of Regulatory Involvement in Japan
\n - Utilizing Local Regulatory Resources
\n
\n\nRobert Russ
ell
\nPresident / CEO \, RJR Consulting\, Inc. \;
\n \;\n
Robert J. Russell (Bob) is President / CEO of RJR Consulting\, Inc. whi
ch specializes in helping clients navigate through Global Regulatory Compl
iance requirements for Pharmaceuticals\, Medical Devices\, Biologics\, Com
bination Products and Dietary Supplement / OTC products. Prior to founding
the company 17 years ago\, Bob had more than 27 years of experience in CM
C\, Global Business development and Regulatory Affairs for two Fortune 200
firms developing innovative Pharmaceuticals and Medical Devices.
\n\n<
p>Bob has specific expertise helping companies expand into new regions glo
bally and meet establishment and licensing requirements\, clinical trial d
ata expectations\, marketing authorization / registration preparation\, me
et variations / amendment filing responsibilities and license renewal fili
ngs. He has practical experience counseling Pharmaceutical and Device manu
facturers through GMP\, GCP\, GLP requirements\, CE marking / ISO certific
ations\, Drug / Device Master File preparation\, mock pre-audits and issue
s management with Global Healthcare Authorities. Bob is a past member of t
he International GMP Working Group on Standards for Industry harmonization
with several colleagues from Europe. He holds a B.S. And M.S. in Chemistr
y.
\n
\nPlease contact Marilyn Turner: Phone: +1 929 900 1853 &n
bsp\;Email: marilyn.turner [a] nyeventslist.com for registrations\n
SUMMARY:Japan Regulatory Compliance Requirements for Life Science Products
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SUMMARY:Japan Regulatory Compliance Requirements for Life Science Products
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