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#1
24th August 2014, 03:58 PM
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| Clinical Data Management And Pharmacovigilance
Will you give me information about Clinical Data Management And Pharmacovigilance courses of the BioMed Informatics Medwin Hospitals ?
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#2
25th August 2014, 02:04 PM
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| Re: Clinical Data Management And Pharmacovigilance
As you want I am here giving the detail of Clinical Data Management And Pharmacovigilance courses of the BioMed Informatics Medwin Hospitals. Clinical Data Management course: Clinical Data Management –CDM is used in clinical research to manage the data of a clinical trial.. CDM (Clinical Data Management) comprises the designing and deploying clinical study and research as well as collecting data and managing data for that clinical study and research. Electronic Processes be used to plan, collect, access, manage the data for the purpose of reporting the entire clinical study of the data. Course curriculum: Clinical Data Management Introduction to Clinical Research Edit Checks Introduction to Clinical Data Management Data Validation Procedures Guidelines for CDM Discrepancy Management Roles and Responsibilities of CDM Team Data Clarification Forms (DCFs) Clinical Data Management Process and Life cycle Database Locking and Freezing Data Management Plan Data Storage & Archival 21 CFR Part 11 Data Coding and Medical Dictionaries CRF Designing SAE Reconciliation CRF Annotation Quality Assurance & Quality Control Data Capture Methods Auditing Data Entry CDISC Standards Pharmacovigilance course : Pharmacovigilance is a discipline that is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine and increasing the safety of drugs in use. It is a discipline of study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation. Course Curriculum Clinical Development process Causality assessment of the adverse event Data Entry Pharmacovigilance in India Adverse Events and its types Importance and procedure of duplicate check Different departments working on Pharmacovigilance Case quality check, Medical review and its submission Four factors for the reportable case Different sources of Adverse Events reporting MEDDRA and WHODD coding PSUR and its submission timelines Different phases of Clinical Trials Case booking or initiation Seriousness criteria of adverse event SAE narrative writing Expedited reporting and its timelines Drug Safety in clinical trials and post marketed drugs Roles and responsibilities of case receipt unit Roles and responsibilities of Triage unit Expectedness or Listedness of adverse event Introduction and responsibilities of USFDA, EMA and CDSCO Different types of AE Reporting Forms History and overview of Pharmacovigilance Case processing Contact detail: BioMed Informatics Medwin Hospitals B Block, First Floor, Nampally, Hyderabad- 500 001, India. Ph: 040-40209750 (G.V.L.P.Subba Rao) Email: ceo@biomedlifesciences.com Email: hrprojects@biomedlifesciences.com Map: [MAP]https://maps.google.co.in/maps?q=BioMed+Informatics++Medwin+Hospitals++++B+B lock,+First+Floor,+++Nampally,+Hyderabad++&hl=en&l l=17.386354,78.498001&spn=0.080926,0.156555&sll=30 .72649,76.668091&sspn=0.583167,1.252441&hq=BioMed+ Informatics++Medwin+Hospitals++++B+Block,+First+Fl oor,+++Nampally,+Hyderabad&radius=15000&t=m&z=13[/MAP] |
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#3
11th January 2016, 01:53 PM
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| Re: Clinical Data Management And Pharmacovigilance
Hi I would like to know about the course offered by BioMed Informatics in the field of Clinical Data Management And Pharmacovigilance?
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#4
11th January 2016, 01:54 PM
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| Re: Clinical Data Management And Pharmacovigilance
Pharmacovigilance is a regulation which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. Pharmacovigilance plays an imperative role in the use of medicines by providing information about ADRs in the general population. Knowledge of the undesirable effects of drugs is important for effective treatment. Features of the course include: Job Oriented Certified guidance Live Project Experience official recognition Placement support Reco correspondence for Abroad Resume groundwork Tips Practical Hands-on tuition on Databases Argus Safety & Oracle Clinical Databases The course curriculum includes the following: Pharmacovigilance Clinical Development process Different phases of Clinical Trials History and overview of Pharmacovigilance Introduction and responsibilities of USFDA, EMA and CDSCO Pharmacovigilance in India Adverse Events and its types Drug Safety in clinical trials and post marketed drugs Different sources of Adverse Events reporting Different types of AE Reporting Forms Expedited reporting and its timelines Different departments working on Pharmacovigilance Roles and responsibilities of case receipt unit Roles and responsibilities of Triage unit Four factors for the reportable case Seriousness criteria of adverse event Expectedness or Listedness of adverse event Causality assessment of the adverse event Importance and procedure of duplicate check Data Entry Case booking or initiation Case processing MEDDRA and WHODD coding SAE narrative writing Case quality check, Medical review and its submission PSUR and its submission timelines Clinical Research Introduction to Clinical Research IRB / IEC Pharma Research/Drug Development Process Informed Consent Process Pre-Clinical Research Roles and Responsibilities of Clinical Trial Team Clinical Trial Phases (I - IV) Site Initiation Study IND/NDA/ANDA CRF & e-CRF Ethics in Clinical Research Standard Operating Procedures (SOPs) ICH-GCP Guidelines Investigator Brochure (IB) Regulatory Affairs Protocol Design and Format US FDA Guidelines Investigational Product (IP) DCGI/Schedule Y Essential Documents for a Clinical Trial EMA Submission & Publication of Clinical Study Report CRO Industry Audits & Inspections Clinical Data Management Introduction to Clinical Research Edit Checks Introduction to Clinical Data Management Data Validation Procedures Guidelines for CDM Discrepancy Management Roles and Responsibilities of CDM Team Data Clarification Forms (DCFs) Clinical Data Management Process and Life cycle Database Locking and Freezing Data Management Plan Data Storage & Archival 21 CFR Part 11 Data Coding and Medical Dictionaries CRF Designing SAE Reconciliation CRF Annotation Quality Assurance & Quality Control Data Capture Methods Auditing Data Entry CDISC Standards Contact Details: BioMed Informatics Medwin Hospitals B Block, First Floor, Nampally, Hyderabad- 500 001, India. Ph: 040-40209750 (G.V.L.P.Subba Rao) Email: ceo@biomedlifesciences.com Email: hrprojects@biomedlifesciences.com |
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