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VERSION:2.0
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CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T193039Z
UID:78e8c2fd-bd0c-4f34-89c7-01a0f3e6d1cd
DTSTART:20210401T100000
DTEND:20210402T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nThis will enable you to meet the new internati
onal GCP standard to ensure regulatory compliance and the acceptance of cl
inical trial data by the regulatory authorities internationally.
\n\nWhy should you Attend:
\nWith the new ICH GCP E6 Revision 2 Add
endum now finalised the changes should have been implemented for organisat
ions running clinical trials.
\n
\nAreas Covered in the Session:
\nReview the new requirements for Sponsor and Investigator Oversight
\nUnderstand requirements for CROs\, quality systems
\nExplore
risk based approaches for clinical trials
\nConsider changes for the
TMF
\nBest practice for Clinical QMS
\n
\nWho Will Benefit:
\nGlobal Clinical Safety and Pharmacovigilance Officers
\nCompl
iance Staff
\nClinical Quality Auditors
\nQuality Assurance Pers
onnel
\nDocument management
\n
\nSpeaker Profile:
\nDr
. Laura Brown \, PhD\, MBA\, Diploma Clinical Sciences\, is an independent
QA and training consultant in the pharmaceutical
\nindustry. She is
a managing director with LB Training and Development Ltd.\, course directo
r for the M.Sc. in Clinical Research\,
\nSchool of Pharmacy at the Un
iversity of Cardiff\, and course director for M.Sc.
\n
\nEvent F
ee: One Dial-in One Attendee Price: US $150.00
\n
\nContact Deta
il:
\nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407\nEmail: compliance4all14@gmail.com
SUMMARY:Compliance with the New ICH GCP Revision 2 Addendum
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SUMMARY:Compliance with the New ICH GCP Revision 2 Addendum
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