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Online Training - Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project Experience Certification & Placement Assistance, Pharmacovigilance Training Argus Safety certificate course in Hyderabad, India consists of online Pharmacovigilance training Argus Safety / online Drug Safety training Argus Safety for the students across the Globe to Countries like India, USA, UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada over World Wide Web. Drug Safety Argus Safety Software online Training course also offered in Hyderabad, Chennai, Bangalore, Mumbai, Pune, Delhi, Kolkata. BioMed Informatics Medwin Hospitals Online Training complimented as the best Pharmacovigilance Training in Hyderabad, best Pharmacovigilance Training in Chennai, best Pharmacovigilance Training in Bangalore, best Pharmacovigilance Training in Mumbai, best Pharmacovigilance Training in Pune, best Pharmacovigilance Training in Delhi, best Pharmacovigilance Training in Kolkata, best Pharmacovigilance Training in India. Pharmacovigilance Argus safety online Training institute features include Interactive one to one sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Training via Skype/TeamViewer with course material and resume preparation tips.

Online Training - Pharmacovigilance/ Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project Experience Certification & Placement Assistance

BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Pharmacovigilance Oracle Argus Safety Drug Safety Training in Hyderabad since the year of 2000. Online Pharmacovigilance Oracle Argus Safety Drug Safety Training in Hyderabad, India includes best Pharmacovigilance Oracle Argus Safety Drug Safety Training online Institute that imparts knowledge about the process of handling data from clinical up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Pharmacovigilance Training in USA, best Pharmacovigilance Training in UK, best Pharmacovigilance Training in Australia, best Pharmacovigilance Training in Germany, best Pharmacovigilance Training in Sweden, best Pharmacovigilance Training in Netherlands, best Pharmacovigilance Training in Singapore, best Pharmacovigilance Training in Europe, best Pharmacovigilance Training in Canada. Training in Online Pharmacovigilance Oracle Argus Safety Drug Safety is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. Pharmacovigilance (PV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Oracle Argus Safety is a Drug Safety Database application for processing, analysing and reporting adverse event cases. It is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. With the rising innovations and the rapid growth in healthcare sector, the demand for quality data pertaining to clinical research has been increased. Pharmacovigilance, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Argus Safety to conduct Clinical Trials.

Pharmacovigilance Training

Pharmacovigilance Is the study of two primary outcomes in the pharmaceutical industry: Safety And Efficacy. Pharmacovigilance is required through the entire life cycle of a drug - starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market. Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.

If you're looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, Drug safety training is crucial. Compliance to European and American pharmacovigilance regulations is important.

Brexit and implementation of the new regulatory base of pharmacovigilance in the UK, as well as in the Eurasian Economic Union (EAEU) countries, have transformed Pharmacovigilance to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Pharmacovigilance has been discussed as a concept for integrated regulations. Considering the recent developments, we are Getting Closer Harmonized systems.

Pharmacovigilance Training Online

Looking for professional pharmacovigilance training? If you hold an associate's degree or higher and want to advance your career in Pharmacovigilance or want to increase your skillset with the Argus Safety Database, our Online Training - Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Flexible Timings & Project Experience Certification with Placement Assistance is right for you to boost your career. Our Drug Safety Associate training online focuses on ICH-GCP/FDA (US)/EMEA (Europe, the Middle East and Africa)/Canada (Health Canada)/TGA (Australia)/MHRA (UK) guidelines, and hands-on argus safety database training. Unique program designed for professionals aspiring to make a career in Drug Safety using the in-demand, industry-based Oracle Argus Safety Database Software.

Online Training Features

  • Web based classroom
  • One faculty/student
  • Placement support
  • Regular/Fast track/Weekend individual slot
  • Flexible timings
  • Training Mode: Skype/Teamviewer
  • Hands-On Training on the Database
  • Direct access to Oracle Clinical Database

Certification

Course Certificate & Job Experience Certificate would be awarded at the end of the program.

Course Curriculum

  • Clinical Development process
  • Different phases of Clinical Trials
  • SOPs, Protocol, Investigators Brochure
  • Informed Consent process
  • SAE reconciliation
  • IRB/IEC
  • ICH-GCP Guidelines
  • History and overview of Pharmacovigilance
  • Introduction and responsibilities of USFDA, EMA and CDSCO
  • Pharmacovigilance Scenario
  • Adverse Events and its types
  • Passive pharmacovigilance-Spontaneous reporting
  • Active Pharmacovigilance-Cohort Event Monitoring
  • Drug Safety in clinical trials and Post Marketing Surveillance
  • 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
  • Signal Detection & Risk Management
  • Importance and procedure of duplicate check
  • Data Entry
  • Case bookin or initiation
  • Case processing
  • MedDRA and WHODD coding
  • SAE narrative writing
  • Case quality check, Medical review and its submission
  • PSUR and its submission timelines


Practical Hands-on Training on Oracle Argus Safety Database

    Argus Console

  • PV Overview
  • PV Business process
  • Introduction to Oracle Argus Safety Database
  • Family, Product and License creation
  • Study creation
  • Sites, users and Groups creation
  • Workflow Configuration
  • Expedited Report Configuration
  • Case priority Configuration
  • Case Numbering
  • Field Validation
  • Code list Configuration
  • LAM (Local Affiliate Module) Configuration

    Argus Safety

  • Different icons used during the case processing and their purpose
  • Different tabs used in case processing
  • Case Routing Based on workflow
  • Minimum requirements for a case bookin
  • Duplicate case check or verification
  • Case Bookin and Data entry
  • Case Processing
  • Case Quality check
  • Medical review of Individual Case Safety Reports (ICSRs)
  • Narrative Writing
  • Case Bookin in LAM and Routing to Central Safety database
  • MedDRA and WHO DD coding
  • Report Generation for Regulatory Submission
  • Expedited Reports and Aggregate Reports
  • Periodic Reports: PSURs, CTPRs, IND and NDA

You will be extensively involved in Argus Safety

  • Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
  • Processing of all incoming cases in order to meet timelines
  • Writing a detailed medically oriented description of the events in the form of safety narrative.
  • Perform the duplicate search in Argus safety database
  • Assessment of seriousness, expectedness/listedness of Adverse Events
  • Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
  • Performing QC review of the cases to meet case processing timelines
  • Coding of adverse events with the help of MedDRA and labeling the events
  • Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
  • Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
  • Preparation of PSURs for regulatory submissions
  • Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to central Argus safety
  • Codelist Configuration in Argus console
  • Creating Sites, Users, User groups
  • Creating Products, Licenses, Studies and Expedited Reporting Rules
  • Configuring Workflow States and rules
  • Knowledge of Advanced conditions; Setting up of field validation to ensure consistency of data

Global Pharmacovigilance Regulations

  • Australia - Therapeutic Goods Administration (TGA)
  • New Zealand - MEDSAFE
  • North America
  • Canada - Health Canada
  • USA - FDA: Food and Drug Administration
  • Central/South America
  • Argentina - ANMAT
  • Brazil - Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Chile - Instituto de Salud Publico (ISP)
  • Columbia - Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
  • Costa Rica - Ministerio de Salud
  • Cuba - CECMED
  • Dominican Republic - Direccion General de Drogas y Farmacias
  • Jamaica - Ministry of Health
  • Mexico - Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
  • Paraguay - Ministro de Salud Publica y Bienestar Social
  • Peru - Ministerio de Salud
  • Uruguay - Ministerio de Salud Publica
  • European Union - EMA: European Medicines Agency
  • Armenia - Scientific Centre of Drug and Medical Technology Expertise
  • Austria - Agency for Health and Food Safety (AGES)
  • Belgium - Federal Agency for Medicines and Health Products
  • Bulgaria - Bulgarian Drug Agency
  • Croatia - Agency for Medicinal Products and Medical Devices of Croatia
  • Cyprus - Ministry of Health
  • Czech Republic - State Institute for Drug Control
  • Denmark - Danish Medicines Agency
  • Estonia - State Agency of Medicines
  • Finland - Finish Medicines Agency
  • France - Agence Nationale de Securite du Medicament et des Produits de Sante
  • Germany - Federal Institute for Drugs and Medical Devices
  • Georgia - Regulation Agency for Medical and Pharmaceutical Activities
  • Greece - National Organisation for Medicines
  • Hungary - National Institute of Pharmacy
  • Iceland - Icelandic Medicines Agency
  • Ireland - Irish Medicines Board
  • Italy - National Institute of Health
  • Lithuania - State Medicines Control Agency
  • Luxembourg - Ministry of Health
  • Malta - Maltese Medicines Authority
  • Moldova - Medicines Agency
  • Netherlands - Medicines Evaluation Board
  • Norway - Norwegian Medicines Agency
  • Poland - The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Portugal - National Authority of Medicines and Health Products
  • Romania - National Medicines Agency
  • Russia - Ministry of Health of the Russian Federation
  • Serbia - Medicines and Medical Devices Agency of Serbia
  • Slovakia - State Institute for Drug Control
  • Slovenia - Ministry of Health
  • Spain - Spanish Medicines Agency
  • Sweden - Medical Products Agency
  • Switzerland - Swiss Agency for Therapeutic Products
  • Ukraine - Ministry of Health
  • United Kingdom - Medicines and Healthcare Regulatory Agency (MHRA)
  • Bahrain - I-SEHA
  • Egypt - Ministry of Health
  • Iran - Ministry of Health
  • Israel - Ministry of Health
  • Jordan - Jordan Food and Drug Administration
  • Lebanon - Ministry of Public Health
  • Saudi Arabia - Saudi Food and Drug Authority
  • United Arab Emirates - Ministry of Health
  • Bangladesh - Directorate General of Drug Administration (DGDA)
  • Bhutan - Drug Regulatory Authority
  • China - CFDA/NMPA: State Food and Drug Administration
  • India - Central Drug Standards Control Organization (CDSCO)
  • Indonesia - POM (Pengawas Obat dan Makanan)
  • JAPAN - PMDA: Ministry of Health, Labour and Welfare
  • Korea (South) - Korean Food and Drug Administration (KFDA)
  • Laos - Food and Drug Department
  • Malaysia - Ministry of Health (MOH)
  • Nepal - Department of Drug Administration
  • Philippines - Department of Health (DOH)
  • Singapore - Health Sciences Authority (HSA)
  • Sri Lanka - Ministry of Health (MOH)
  • Taiwan (Republic of China) - Taiwan Food and Drug Administration (TFDA)
  • Thailand - Food and Drug Administration of Thailand
  • Vietnam - Drug Administration of Vietnam
  • Algeria - Ministry of Health and Population
  • Botswana - Ministry of Health (MOH)
  • Burkina Faso - Le Ministere de la Sante
  • Ghana - Food and Drugs Authority
  • Kenya - Pharmacy and Poisons Board
  • Morocco - Ministry of Health
  • Nigeria - National Agency for Food and Drug Administration and Control
  • Rwanda - Ministry of Health
  • Senegal - Ministere de la Sante et de l'Action Sociale
  • South Africa - Medicines Control Council (MCC)
  • Swaziland - Ministry of Health
  • Tanzania - Tanzania Food and Drug Authority (TFDA)
  • Uganda - National Drug Authority