Fortbildung bei der DGRA e.V.
DGRA-School
3rd School Clinical Documenation
2. - 3. November 2020
Moderation
Termine
Montag, 2. November 2020 | 09.00 Uhr bis 17.30 Uhr
Dienstag, 3. November 2020 | 09.00 Uhr bis 17.30 Uhr Termin in den eigenen Kalender übertragen
Veranstaltungsort
Online Veranstaltung
Download
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Programmvorschau Änderungen vorbehalten
Program November 2nd, 2020
9.00 a.m. I. Introduction to the Clinical Drug Development Process Leading to the Label
Dr. Ingrid Klingmann9.45 a.m. Bio break 9.55 a.m. II. Basics of Clinical Trials Phase I to IV
Dr. Ingrid Klingmann10.40 a.m Coffee break
11.00 a.m. III. Informed Consent Process and Data Protection
Dr. Ingrid Kllingmann11.40 a.m. Bio break
11.50 a.m. IV. Ethical Review Process for Clinical Trials in Europe
Dr. Ingrid Klingmann12.30 p.m. Lunch 1.30 p.m. V. Good Clinical Practice
Dr. Martin Coenen2.15 p.m. Bio break 2.25 p.m. VI. Management of Trial Documents: from Essential Documents to Trial Master File
Dr. Martin Coenen3.30 p.m. Coffee break 4.00 p.m. Ⅶ. Quality Management in Clinical Trials
Dr. Klaus Eckhardt4.45 p.m. Ⅷ. Audits and Inspections
Dr. Klaus Eckhardt5.30 p.m. End of Day 1 Program November 3rd, 2020
9.00 a.m. Ⅸ. Safety Data Collection and Assessment
PD Dr. Thomas Sudhop9.40 a.m. Bio break 9.50 a.m. Ⅹ. Safety Reporting in Clinical Trials
PD Dr. Thomas Sudhop10.30 a.m. Coffee break 11.00 a.m. Ⅺ. Current Clinical Trial Legislation: Directive 2001/20/EC and Commission Directive 2005/28/EC
Dr. Ingrid Klingmann12.00 p.m. Bio break 12.10 p.m. Ⅻ. Clinical Trial Authorisation and Reporting
PD Dr. Thomas Sudhop13.15 a.m. Lunch 2.15 p.m. XIII. Upcoming Clinical Trial Legislation: Regulation 536/2014
Dr. Ingrid Klingmann2.45 p.m. Bio break 2.55 p.m. XIV. Coordinated Assessment Procedures: from VHP to Pilot Projects
PD Dr. Thomas Sudhop3.30 p.m. Coffee break 4.00 p.m. XV. Clinical Development Strategies
Prof. Dr. Thomas Bieber5.30 p.m. End (There maybe changes to the program)
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Kostenbeitrag und Stornierungen
Participation fees:
For DGRA members and M.D.R.A. students: 390 €, for non-members: 540 €Cancellation will incur a handling fee of 50€.
In case of short-term cancellation (2 weeks before) 50 % of the registration fee will be charged.
One week before the event the full fee has to be paid,
unless a substitute participant (DGRA member) is named.In case of cancellation by the organizer, already paid fees will be refunded in full.
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Unterlagen Mitgliedern vorbehalten
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