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(SC 10) Navigating Through Indian Regulatory Terra Incognita
Brijesh Regal, C.E.O., Apothecaries Clinical Research, New Delhi, India (Former WHO Consultant to Drugs Controller General of India, and coordinated the development of Schedule Y)
The workshop will provide a broad
overview of current Indian regulatory scenario as well as the
evolutionary processes currently underway. Granular
issues regarding clinical research regulations will be discussed
in depth.
Case studies will form the core of the workshop. Participants are
advised to send their specific questions and situations which may
be used to simulate some of the case studies to be discussed in
the workshop. There
would be a quiz at the end, and the winners will receive copies of
"Apothecaries White Book for Clinical Research." Key
learning points:
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In-depth understanding of regulations
in general, and Schedule Y in particular, that prescribe
documents for regulatory dossiers
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Inventory and depth level of documents
that need to go into the regulatory dossiers for various phases
of clinical trials or for
products registrations
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Prescribed ICDs for clinical trials
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Preparing documents to be submitted to
ethics committees
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Import and export regulations for
clinical trial material
More Short Courses:
(SC1) BIOMARKERS ARE US: INTERACTIVE
SHORT COURSE ON HOW BIOMARKERS WILL IMPACT THE FIELD OF ONCOLOGY
(SC2) THE CHALLENGE OF THE BLOOD-BRAIN
BARRIER A MEDICINAL CHEMISTRY PERSPECTIVE
(SC3) ADMET CASE STUDIES FROM A MEDICINAL
CHEMISTRY PERSPECTIVE
(SC4) THE EPIGENETIC STEM CELL SIGNATURE
(SC5) IMMUNOLOGICAL BIOMARKERS: "HOW
TO" AND THREE CASE STUDIES
(SC6) CIRCULATING TUMOR CELLS
(SC7) CANCER STEM CELLS
(SC8) MODELS FOR EVALUATING DRUG-DRUG
INTERACTION POTENTIAL IN PRECLINICAL DEVELOPMENT
*Separate Registration
Required
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