BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T150004Z UID:1d26d789-f8b6-43a3-8a46-12beaa889663 DTSTART:20210125T083000 DTEND:20210126T083000 CLASS:PRIVATE DESCRIPTION:
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\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT
CARD! ***
\nREGISTER TODAY!
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\n\nThi s China &\; Pacific Rim life science compliance-based seminar will disc uss the regulatory structure and requirements for compliance with in-count ry regulations for Pharmaceuticals\, Medical Devices\, Biologics and Combi nation Products.
\n\nChina 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 reg ulations\, China will further align the country with international standar ds of practice. For manufacturers and distributors of drugs and medical de vices in China\, it is important to pay close attention to the pace at whi ch SFDA implements these changes and to make changes to their standard ope rating procedures when necessary to ensure compliance with the evolving re gime.
\n\nOther Pacific Rim markets are also growing in importance a nd interest in access to innovative products. In-country Regulatory Agenci es are progressing in their sophistication\, process development and regul atory requirements.
\n\nThis course specifically focuses on the over all regulatory compliance requirements and procedures for Pharmaceuticals\ , Medical Devices\, Biologics and Combination Products in China and the li sted Pacific Rim Countries* (Taiwan\, Hong Kong\, Singapore\, Malaysia\, V ietnam &\; Thailand). The course will cover topics relating to pre-clin ical and clinical requirements\, as well as\, addressing the structure of the regulatory agencies. Content will also include descriptions of the met hods by which regulators process filings and registrations and what is exp ected in the authorization and dossier maintenance of licensed products. p>\n\n
\nSeminar Fee Includes:
\n
\nLun
ch
\nAM-PM Tea/Coffee
\nSeminar Material
\nUSB with seminar
presentation
\nHard copy of presentation
\nAttendance Certifica
te
\n$100 Gift Cert for next seminar
\n
\nLearning
Objectives:
\nThis 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 P
roducts (pharmaceuticals\, medical devices\, biologics\, combination produ
cts) as an importer into China &\; the Pacific Rim. It will provide tra
ining on:
The current Regulatory Structure.
\nUnderstanding the specific procedures for Pharmaceutical s\, Medical Devices\, Biologics and Combination Products.
\nHow to begin your company&rsquo\;s involvement in-country: local l icenses\, personnel and facilities required.
\n \nClini cal Trials: Why consider Country X? CTA requirements\, the Application Pro cess\, CRO Selection and Start-up.
\nThe current key regulations effecting product development and your company'\;s product pipeline.
\nPricing establishment.
\nUnderstanding the local concerns and specific challenges in workin g with Local Regulatory Personnel.
\n \nUnderstanding t he Local Culture: Realistic expectations\, timing on reviews\, effective s trategies for adding China and countries from the Pacific Rim to your comp any'\;s global market presence.
\nInformation nec essary for effective dossier preparation\; or how does one take an already approved dossier and turn it into an acceptable submission package.
\nStrategies for streamlining the registration applicatio n process for faster approval.
\nMaintenance of Auth orized Products.
\n
\nWho will Benefit
:
\nThis course will be beneficial to the followi
ng personnel whose responsibilities require knowledge of these Emerging Ma
rkets'\; regulatory requirements for Life Science products:
Regulatory\, Quality\, Manufacturing\, Global Business Develo pment and General Management personnel whose responsibilities require loca l knowledge of regulatory\, quality and import / export requirements
\nAdministrative staff responsible for ensuring complianc e with regulatory filings and overall GCP\, GMP and GLP compliance require ments will also find this training highly relevant
\nGlobal business development and general management requiring an understan ding of how regulations and compliance issues are culturally handled along with how best to consider China &\; the Pacific Rim into one'\;s Gl obal Business Strategy will profit from attending
\n
\nTopic Back Ground:
\nThe 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 pre
vailed among provincial government agencies\, centralized the Chinese heal
thcare regulatory system\, and made it more transparent to industry partne
rs. The SFDA now oversees all medications. Other former functions of the m
inistry have been assigned to different government bodies. The most import
ant 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\, healthca
re resource allocation\, and medical research and education.
Alo ng with it in 2010\, China has amended GMP\, GLP\, GCP\, GSP and other reg ulations\, China'\;s aim is to further align the country with internati onal standards of practice. For manufacturers and distributors and importe rs of drugs and medical devices in China\, it is imperative to pay close a ttention 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 regim e.
\n\n \;
\n\nAGENDA
\n\n
\n<
strong>DAY 1 - China(8:30 AM - 4:30 PM)
\n8:30 &ndash\; 9:00 AM: Registration
\n9:00 AM: Session Start Time&n
bsp\;
\nCountry Profile / Healthcare System.
\nKey Country Infor
mation.
\nStrategic Considerations: Why focus on this country? / Asia
Structure / Hub Locations.
\nGovernmental &\; Regulatory Authorit
ies / Agencies / Structure.
\nCompany Establishment\; Licenses &\;
Key Personnel
\nPartner Companies / Local Relationship Options.
\nIn-Country Operational Considerations\; Importance of Local Distributor
s.
\nRequirements to Conduct Clinical trials / Approvals / GCP
\
nLicensing Products (Innovative Drugs \, Generics / Similars\, Orphan Drug
s\, Biologics / Vaccines\, Medical Devices).
\nVariations and Amendme
nts to Licenses.
\nGMP and Inspections.
\nPackaging and Labeling
.
\nPrice Establishment.
\nReimbursement.
\nImport / Export
/ Customs Clearance.
\nTaxes / Duties.
\nAdvertising &\; Pro
motion.
\nVigilance Reporting / Post-Marketing Requirements.
\nP
atents &\; Trademarks.
\nLocal Customs / Cultural Issues / Establi
shing Business Relationships.
\nWorking with Local Agencies / Authori
ties.
\nConclusions.
\nDAY 2 - A high-lev
el review of following topics for Taiwan\, Hong Kong\, Singapore\, Malaysi
a\, Vietnam &\; Thailand(8:30
\nAM - 4:30 PM)
\nCountry Profile / Healthcare System.
\nKey Country Inform
ation.
\nStrategic Considerations: Why focus on this country? / Asia
Structure / Hub Locations.
\nGovernmental &\; Regulatory Authoriti
es / Agencies / Structure.
\nCompany Establishment\; Licenses &\;
Key Personnel
\nPartner Companies / Local Relationship Options.
\nIn-Country Operational Considerations\; Importance of Local Distributors
.
\nRequirements to Conduct Clinical trials / Approvals / GCP
\n
Licensing Products (Innovative Drugs \, Generics / Similars\, Orphan Drugs
\, Biologics / Vaccines\, Medical Devices).
\nVariations and Amendmen
ts to Licenses.
\nGMP and Inspections.
\nPackaging and Labeling.
\nPrice Establishment.
\nReimbursement.
\nImport / Export
/ Customs Clearance.
\nTaxes / Duties.
\nAdvertising &\; Prom
otion.
\nVigilance Reporting / Post-Marketing Requirements.
\nPa
tents &\; Trademarks.
\nLocal Customs / Cultural Issues / Establis
hing Business Relationships.
\nWorking with Local Agencies / Authorit
ies.
\nConclusions.
\nSPEAKER
\nRobert J.
Russell
President of RJR Consulting\, Inc
\n\n
\nRobert J. Russell\, (Bob) is the President of RJR Co
nsulting\, Inc.\, a Global Regulatory Consulting company\, specializing in
understanding regulatory issues for the pharmaceutical\, medical device a
nd 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 t
hese regions. Licensing\, registrations\, GMP\, DMFs and borderline produc
ts are core competencies of the Course Director.
Prior to enteri ng the consulting field\, Mr. Russell was the Global Director of Regulator y Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR'\;s offices are located in every major region with in-country exper ts on staff handling local regulatory needs. Bob has a BS and MS in Chemis try.
\n\n \;
\n\nPlease contact the event manager Marilyn
(marilyn.b.turner@nyeventslist.com \;) below for:
\n- Multiple pa
rticipant discounts
\n- Price quotations or visa invitation letters\n- Payment by alternate channels (PayPal\, check\, Western Union\, wi
re transfers etc)
\n- Event sponsorships
\n
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LOWED ON REGISTRATIONS
\nService fees included in this listing.
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