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How to Fill an ADR Form Dr. Manish Barvaliya, Assistant Professor,
Department of Pharmacology, GMERS Medical College, Dharpur, Patan. Mobile:
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August 6, 2019
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Pharmacovigilance CME : Bhavnagar
ADR Form Standard form provided by CDSCO, Government of India Four Sections Patient Information Suspected Adverse Reaction Suspected Medications Reporter August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Pharmacovigilance CME : Bhavnagar
Patient Information August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Suspected Adverse Reaction
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Suspected Medications
Rechallenge may be incidental or planned prospective re-exposure. History is very important or review of past medical records is important for Rechallenge information August 6, 2019
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Pharmacovigilance CME : Bhavnagar
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Pharmacovigilance CME : Bhavnagar
Reporter August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Pharmacovigilance CME : Bhavnagar
Confidentiality August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Essential Requirements (point no. 1, 5, 7, 8, 11, 15, 16 & 18 )
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Essential Requirements
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Essential Requirements
August 6, 2019
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Essential Requirements
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Pharmacovigilance CME : Bhavnagar
August 6, 2019 Pharmacovigilance CME : Bhavnagar
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Pharmacovigilance CME : Bhavnagar
It’s time for some activity! August 6, 2019 Pharmacovigilance CME : Bhavnagar
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CBC, LFT, RFT values √ KNP 67 years F _ Re-challenge not performed
08/02/2013 21/02/2013 Patient developed rashes on the backs of hands, arms, trunk, neck, and face and frank blistering in some areas after 2 months of taking gliclazide. Lesions on lips and inside mouth. Diagnosis: Erythema Multiformae DM for 4 years, Stroke 5 years back Gliclazide 40mg oral once daily 2months back 10/02/2013 Type 2 DM √ Re-challenge not performed Aspirin 75mg once daily for 5 years Ramipril 10mg once daily Simvastatin 40mg at night,Metformin 1g twice daily X for 4 years Aditya Gajera, Second M.B.B.S, Govt. Medical College, Bhavnagar M): Probable/likely /02/2013
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