BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T123815Z UID:2196720d-92e0-4fee-a116-a65631fa0e06 DTSTART:20201130T083000 DTEND:20201201T083000 CLASS:PRIVATE DESCRIPTION:
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\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON
GIFT CARD! ***
\nREGISTER TODAY!
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\n\nThis two-day comprehensive Course on Latin America Regu latory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration\, amendments and r enewals across Pharmaceuticals\, Biologics\, Medical Devices and Combinati on Products. The Course will address the structure of the regulatory agenc ies in Latin America and discuss local cultural nuances to help you be suc cessful in working with the regulators.
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\n\nThis course specifically focuse s on the overall regulatory compliance requirements and procedures for Pha rmaceuticals\, Medical Devices\, Biologics and Combination Products in Lat in America. The primary countries covered will include: Argentina\, Brazil and Mexico. Other countries such as Chile\, Costa Rica\, Dominican Republ ic\, Panama\, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements\, as well as\, a ddressing the structure of the regulatory agencies in Latin America. Conte nt will include descriptions of the methods by which regulators in the cor responding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of the wide array of license d products.
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\n\nSeminar Fee Includes:
\n
\nLunch
\nAM-PM Tea/Coffee
\nSeminar Material<
br />\nUSB with seminar presentation
\nHard copy of presentation
\nAttendance Certificate
\n$100 Gift Cert for next seminar
The current regulatory climate in Latin America is discussed in detail an d several examples will be provided to illustrate effective compliance pro cedures and techniques. Common issues that have caused difficulties for Li fe Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they r elate with other National Healthcare Authorities. Additionally\, participa nts will learn how personnel can best address the conflicts\, which arise and the best course for resolution.
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\n\nWh o Will Benefit:
\n\nThis course will be beneficial to:
\ n\nRegulatory personnel whose responsibilities require kn owledge of Latin America'\;s regulatory environment
\nAdministrative staff responsible for ensuring compliance with regulat ory filings and overall regulatory compliance requirements will also find this training highly relevant.
\nQA / QC Personnel p>\n
Global Supply Chain personnel
\nClinical / Pharma &\; Device personnel
\nManuf acturing personnel
\nGlobal Business Development per sonnel
\nAny sales or general management employee re quiring an understanding of how regulations and compliance issues impact t he organization
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\n\nAGENDA<
/strong>
\n \;
Day 01(8:30 AM - 4:30 PM)
\n\n8:30 &ndash\; 9:00 AM: Registration
\n9:00 AM: Session S
tart Time \;
\nLA Overview
\nLA markets
\nHarmonization
efforts
\nUnderstanding the Regulatory Process
\nRegulatory Ove
rview (gov'\;t offices\, organization\, contact info)
\nBrazil - A
NVISA
\nMexico &ndash\; COFEPRIS
\nArgentina &ndash\; ANMAT
\nCountry Establishment
\nClinical Trials
\nClinical Trial Star
t-up
\nClinical Trial Application
\nIND'\;s
\nReporting<
br />\nGCP
\nScientific advice
\nStability studies
\nPharma
ceuticals
\nMarketing Authorizations/Registrations
\nRegistratio
n requirements
\nRegistration documentation/CTD
\nSummary of Pro
duct Characteristics
\nPackage insert
\nLabeling
\nPharmaco
vigilance/Post-marketing
\nAmendments/Variations/Changes/Renewals
\nFees
\nSubmission Process
\nPaper filings
\nElectronic
filings
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\n\nDay 02(8:30 AM - 4:30 PM)
\n\nGenerics &\; Bioequivalence
\nBiologics
\nComp
assionate use
\nOrphan drugs
\nMedical Devices
\nDevice Cla
ssification
\nTesting Standards
\nRegistrations
\nAmendment
s/Variations/Renewals
\nCost build-up model
\nFees
\nPost-m
arketing
\nCombination products
\nPatents/Copyrights/Trademarks<
br />\nImport/Export procedures
\nTax exemptions
\nAdvertising/P
romotion
\nComparing &\; Contrasting LA and US
\nChallenges i
n Latin America
\nInfluencing the Regulatory Process
\nConclusio
ns &\; summary
\nSPEAKER
\nPresident of RJR Consulting\,
Inc
Robert J. Russell\, (Bob) is the President of RJR Consulting\, Inc.\, a Global Regulatory Consulting company\, specializing in understanding regulatory issues for the pharmaceutical\, medical device and combination products industry. Bob has more than 30 years of experien ce working with FDA\, EMA\, Healthcare Authorities and Agencies across Lat in America\, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing\, registrations\, GMP\, DMFs and borderline prod ucts are core competencies of the Course Director.
\n\nPrior to ente ring the consulting field\, Mr. Russell was the Global Director of Regulat ory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices . RJR'\;s offices are located in every major region with in-country exp erts on staff handling local regulatory needs. Bob has a BS and MS in Chem istry.
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\n\nPlease contact the event manager Marily n (marilyn.b.turner@nyeventslist.com ) below for:
\n\n- Multiple par
ticipant discounts
\n- Price quotations or visa invitation letters
\n- Payment by alternate channels (PayPal\, check\, Western Union\, wir
e transfers etc)
\n- Event sponsorships
\n
\nNO REFUNDS ALL
OWED ON REGISTRATIONS
\nService fees included in this listing.
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This event is brought to you by:
\nMETRICSTREAM INC - New York Events
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\nhttp://www.NyEventsList.com
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\nROC181018CEL