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DTSTAMP:20260523T044401Z
SUMMARY:Webinar on Reporting Adverse Event - Regulatory Requirements
DESCRIPTION:Overview: Before the celebration of a successful clinical 
 development of a novel therapeutic molecule, the teams face several ye
 ars of challenges with the drug development process.\nIn early drug de
 velopment when just an idea has been placed on a path to clinical deve
 lopment the project team identifies the possible risk associated with 
 that class of drug. This webinar has been designed to discuss the term
 inology and definitions of adverse events and to compare the differenc
 e between an event and an adverse reaction. Anticipated and unanticipa
 ted adverse events will be discussed with examples provided to clarify
  the differences. By understanding the terminology involved a more acc
 urate analysis of the safety data can be achieved. Significance of the
  analysis will determine whether the data should be reported to the sp
 onsor (Pharmaceutical company) and/or the FDA. The webinar will discus
 s the role of the principal investigator in the reporting process duri
 ng the clinical trials.\nWhy should you Attend:\nThe ultimate goal of 
 the clinical development process is to successfully conduct the approp
 riate clinical trials that will be on a path of final approval by the 
 Food and Drug Administration (FDA). In effort to avoid clinical failur
 e, an important aspect of the process is to understand drug safety bot
 h during the investigational stage (clinical trials) and the marketing
  phase (post-approval). In the investigational stage the Institutional
  Review Board (IRB) continues to review the study at appropriate inter
 vals defined by the risk of the study “to assure the protection of t
 he rights and welfare of human subjects”.\nAreas Covered in the Sess
 ion:\nDrug Safety During Clinical Development and Post-MarketingAdvers
 e Event IdentificationAdverse Reporting RequirementsICH Roles in Drug 
 Safety ProcessRole of the IRB in the Safety Document ReviewCompare Adv
 erse Reporting in United States and EuropePost-Approval Risk Assessmen
 t SystemVoluntary Physician and Consumer Reporting System - MedWatch\n
 Who Will Benefit:\nRegulatory affairs officeMedical affairs officeQual
 ity Assurance and Quality ControlClinical Research OrganizationsAdmini
 strative/Data ManagementRegulatory Compliance Associates and ManagersS
 tatistical and Data Analysis Managers\nSpeaker Profile:\nHarold Thibod
 eaux is a medical research scientist with in vivo pharmacological expe
 riences in both academia and biopharmaceutical industry. During his pr
 estigious career the focus of Mr. Thibodeaux’s research efforts has 
 been on the efficacy of cardiovascular drugs most notably Hypertension
 , Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmon
 ary Research and topical antibiotics. Optimal therapeutic benefits wer
 e the goal in all of these projects but cardiovascular safety to provi
 de safer medicines to patients was a priority. Mr. Thibodeaux transiti
 oned into the pharmaceutical industry when he joined the Cardiovascula
 r Department of Genentech in 1990, as a technical lead with the Second
  Generation TPA Project Team. \nContact Detail:\nNetZealous - Complia
 nce4All,161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA.Phone
 : +1-800-447-9407Email: support@compliance4All.comhttp://www.complianc
 e4all.com/Event Link : http://bit.ly/1NbwjFF\n\nFor more information 
 visit https://medtechiq.ning.com/events/webinar-on-reporting-adverse-e
 vent-regulatory-requirements
DTSTART;TZID=America/New_York:20160128T100000
DTEND;TZID=America/New_York:20160128T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:
URL:
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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