Pharmacovigilance argus safety

Type Training Institute GIPHS Providing Pharmacovigilance Training On Oracle Argus Safety Databasse 7.0 With MedDRA and WHODD Medical Coding

Pharmacovigilance online training Pharmacovigilance Basic: Legal basis for safety coverage as well as a historical perspective Basic definitions and tools Pre- and Post-marketing: Basic variations Pre-Marketed AEs Post-Marketed AEs The Importance of Adverse Event coverage Suspected sudden Serious Adverse Reaction Sources of ADRs Causality Lack of effectiveness Expectedness Minimum Criteria for coverage Expedited coverage An introduction to the Eudravigilance system Qualified Person for Pharmacovigilance (QPPV) needs Development Safety Update Reports European communication laws New EU Pharmacovigilance Legislation Pharmacovigilance Advanced: Types of Audits & Inspections Approaches Preparing for a Pharmacovigilance scrutiny Overview of the Pharmacovigilance Audit Best Practices Detailed Audit things Need for detection The Cost of Failure Signalling summary Regulatory needs Signal Detection Objectives Incidence, Numerator, divisor Need for the ready Mind Signal Detection Hierarchy Approach to detection Signalling Examples Risk assessment and management For more details: Hno , road no: 3 New Dilshuknagar nagar colony Dilshuknagar,Hyderabad – ,India Mobi No:+, Land line No: 040

Pharmacovigilance online training with ARGUS database with real time expert trainers at Groupware Training. The only institute in Hyderabad having expert real time trainers. This is not saying by us, saying by our previous students. Mobile: +91-

Type Training Institute GIPHS Is Providing Pharmacovigilance Training on Oracle Argus Safety Database 7.0. With MedDRA & WHODD Medical Coding.GIPHS (Global Institute OF Advanced Pharmaceutical & Health Sciences) is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates. The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Training in Clinical Data Management (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.

Type Training Institute GIPHS Providing Pharmacovigilance Training On Oracle Argus Safety Database 7.0.3 Version With MedDAR and WHODD Medical Coding.

Gratisol Labs is a leading Contract Research Organisation (CRO) head quartered at Hyderabad. With our Academy of Clinical Research we have been shaping careers for various Medicine/ Pharmacy/ Life Sciences students. At our Lucknow office we have achieved 70% placement results. We invite you to acquire a professional knowledge in Pharmacovigilance / Medical Writing / Clinical Research and secure your success in Pharma Healthcare & IT Industry by being a part of these growing fields and with our programs. Gratisol Labs Academy of Clinical Research, Lucknow is pleased to announce the start of our Next Internship batch of Pharmacovigilance Program & Clinical Research Management Program. Eligibility: Pharma, Medicine and Life Sciences gradudate and post graduates. PLACEMENTS Our Placement Team continuously works tirelessly to keep our students posted on various openings in the industry. We provide 100% placement support to every student of ours. Contact Us at: Gratisol Labs st floor, Indira Nagar, (Beside Smriti Vihar Park), Lucknow-

Pharmacovigilance Training & Placements The course modules cover theoretical aspects of pharmacovigilance through a structured curriculum. The course will put emphasis on interactive sessions with the participants, hands-on approach on the Argus database with case assignments, group discussions and quizzes as evaluation components Overview of Pharmacovigilance Regulatory Aspects of Pharmacovigilance Periodic Safety Updates Reports(PSUR's) Suspected Unsuspected Serious Adverse Reactions Care Reporting Process Eudra Vigilance Signal detection Process and tools Safety Intelligence Practical and Hands- on Oracle Argus Data Base Eligibility criteria for admission Applicant should have a Bachelor’s or Master’s Pharmacy & MBBS And All Medicine Students. Pharmacovigilance is a growing sector. With increased outsourcing and the advent of tightened regulations by the regulators, there will be a lot of scope for professionals who are ‘pharmacovigilance-ready’. The placement opportunities can be from CROs, BPOs or Pharmaceutical companies. Course Duaration: 2months (50) Contact: Lara Clinical Research #nd floor,Nilgiri Block,Aditya Enclave Ameerpet,Hyderabad Get Trained and Placed in Pharma, CRO, MNC Industries Do you have a Background in Science, Medicine or Related Area? Do you wish to pursue a career in Clinical Research Industry? Do you wish to become a Clinical Research professional? Do you wish to become a Clinical Data Professional? Do you wish to become a SAS Programmer or Analyst? Do you wish to become a Drug safety Associate (PV) Professional? Do you wish to become a Medical Coder professional? If your answer to any of the above question is “YES” then Contact us to get you started on diverse Training opportunities in Lara Clinical Research Training Institute. Lara Clinical assists life science and healthcare professionals achieve success by delivering specific solutions for their individual needs, our Popular Training Programmes. Course Curriculum: 1)Clinical Research & Data Management 2)Clinical Data Management & Pharmacovigilance 3)Clinical Data Management with SAS Clinical Programming 4)Pharmaco vigilance 5)Medical Coding 6)CDISC/SDTM 7)SAS-Clinical To enroll in any of these courses and packages tailored to to your needs contact at any by emailing Lara Clinical Research, Ameerpet Hyderabad Calling Pharmacy professionals, Medicine professionals, Life science Studnets, IT Students Training will be conducted in Hyderabad Ph: 040-,

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. FOR ONLINE TIMINGS: PM TO PM FOR CLASS ROOM TIMINGS: AM TO PM ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains studentswith hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM,SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room,Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S/B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. MAIL ID: WEBSITE: www.igcp.co.in FOR ONLINE TIMINGS: PM TO PM FOR CLASS ROOM TIMINGS: AM TO PM ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

100% Job Oriented Medical Billing Coding/Medical Internship Training With Placements:- Organization at a Glance: Global Institute Of Advanced Pharmaceutical & Health Sciences (GIPHS) is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We Provide contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to experienced professionals as well as entry level candidates. The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Hands on Software Training in Clinical Data Management (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM, Medical Coding, Clinical Coding (MeDRA & WhoDrug Dictionaries) & SAS to aspirants of Clinical Research Industry. We successfully help the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals. Global Institute Of Advanced Pharmaceutical & Health Sciences (GIPHS) also provides Site Management Services, Clinical Data Management, Pharmacovigilance, Medical Writing, Medical Coding, Medical Billing, Biostatistical Analysis, SAS Programming & IT Support Services to Pharmaceutical, Biotechnology and Medical Device Organizations globally. Mode of Training- Classroom/Online Alternative day exams with focus on CPC and CCS Certification preparation. • Daily exams. • Physician and Hospital coding. GlPHS(Global Institute Of Advanced Pharmaceutical & Health Sciences)Labs Advantages: • Own Medical Coding live projects • Highest Placement record across all training institutes • Industry SOPs based training • Trainers with minimum 5 years experience The focus of the lectures will be mainly on the following topics: ICD Coding (Diagnosis Coding) CPT Coding (Procedures Coding) HCPCS Coding (Supplies Coding/Drugs Coding), Hospital Coding CPC and CCS Preparation HIPAA ComplianceICD Coding (Diagnosis Coding) CPT Coding (Procedures Coding) HCPCS Coding (Supplies Coding/Drugs Coding) Hospital Coding • CPC and CCS Preparation • HIPAA Compliance Clinical Coding • MedDRA • Structure and Content • Comparison to COSTART • Coding and the Points to Consider Document • Standardized MedDRA Queries (SMQs) • Versioning • CTCAE Mapping to MedDRA • Regulatory Expectations • Overview of the MedDRA dictionary (structure and format) • General coding principals based on the current MedDRA Points to Consider • Practical exercises in MedDRA coding • General analysis and reporting principals based on the current MedDRA Data Retrieval and Presentation: Points to Consider • Practical exercises in MedDRA analysis and reporting • Review of MedDRA • Rules and Conventions Used In MedDRA • MedDRA Term Selection: Points to Consider Document • Discussion of the Coding Examples Provided in the “Points to Consider” Document • Additional Coding Examples to Further Explain the Term Selection Points • Importance of Company Coding Conventions • WHO Drug • Review of WHO Drug • Identifying the Drug • Using a "Fuzzy" Search Engine • Search Using Google • Martindale Online • Other Web Resources • General Principles for Selecting the Appropriate WHO Drug Entry • Abbreviations • Handling Drugs with Multiple WHO Drug Entries • Special Rules for Coding Certain Drugs and Drug Categories • Multi-Ingredient Drugs • Querying Terms • Importance of Company Coding Conventions • Change Request Process • Coding Herbal Medicines • Coding Investigational Products • Coding Vaccines • Coding Multivitamins • Handling Reported Non-Therapies • Application and Use of ATC Codes • Practical Exercises in WHO Drug Coding • The Following Chapters are discussed in detail • Integumentary System coding • Musculoskeletal System coding • Respiratory System coding • Cardiovascular System coding • Digestive System coding • GenitoUrinary System coding • Neurology coding • Sense Organs coding • Radiology coding • Pathology coding • Medicine coding and Medical Billing in detail • HIPAA compliance • This course will provide training in the core competencies in Medical Coding including fundamentals of clinical trials. It's a great program for industry professionals who are looking to advance their careers or seeking industry certifications and anyone looking to enter the clinical research & Health Care Industry. We are certified members of American Academy of Professional Coders. GIPHS (Global Institute Of Advanced Pharmaceutical & Health Sciences Comprehensive Medical Coding training program provides you with the training and practical experience you need to develop the skills necessary to work as a medical coding and billing professional. Prepares you to perfection to pass national medical coding certification exams Covers the complete syllabus and meets requirements for both the AHIMA and AAPC certification exams, including the CCA, CPC, and CPC-H. As a certified coder, you will be in high demand in the job market. Instructors with Onsite/Real time experience and Certified in the field. Instructors have "been there, done that" and know not only what it takes to create career opportunities in your field of interest but also how you'll be able to apply your industry-current education once you make your move. Career-focused training programs with concentrations to help you build relevant credentials Live Project Training with Internship will also be provided in Health Care BPOs. Mode of training- Instructor Led Class room/ Online Training Tenure: 2 month Eligibility Applicants are recommended to have Any life Science degrees: Bachelor's(B.Sc Life Sciences), Master’s (M.Sc Life Sciences), or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (companies, CROs and Hospitals. Certification: Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Global Institute Of Advanced Pharmaceutical & Health Sciences For more information, please contact Global Institute of Advanced Pharmaceutical & Health Sciences at Training Location (Venue) GIPHS (Global Institute of Advanced Pharmaceutical & Health Sciences) Academy of Clinical Research KVR Enclave, #nd Floor,Beside Satyam Theater,Near Maitrivanam, Ameerpet, Hyderabad. Contact Information Dr.Anita Singh Training Coordinator Mob No:+91

ADVANCED CERTIFIED PHARMACOVIGILANCE TRAINING WITH HANDS ON TRAINING IN ORACLE ARGUS SAFETY DATABASE, MedDRA & WHODD Browsers with 100 % placements Assistance. Organization at a Glance: Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals andss entry level...

Details: Topic I: Pharmaco-vigilance, Risk Management, and Compliance to Clinical Safety Topic II: Adverse Drug Reactions and Safety Reports Topic III: Clinical Trials and Regulations Topic IV: Signal Analysis and Pharmacovigilance Regulations Topic V: Pharmacovigilance Management and Importance Research Study

Get Trained and Placed in Pharma, CRO, MNC Industries Do you have a Background in Science, Medicine or Related Area? Do you wish to pursue a career in Clinical Research Industry? Do you wish to become a Clinical Research professional? Do you wish to become a Clinical Data Professional? Do you wish to become a SAS Programmer or Analyst? Do you wish to become a Drug safety Associate (PV) Professional? Do you wish to become a Medical Coder professional? If your answer to any of the above question is “YES” then Contact us to get you started on diverse Training opportunities in Lara Clinical Research Training Institute. Lara Clinical assists life science and healthcare professionals achieve success by delivering specific solutions for their individual needs, our Popular Training Programmes. Course Curriculum: 1) Clinical Research & Data Management 2) Clinical Data Management & Pharmacovigilance 3) Clinical Data Management with SAS Clinical Programming 4) Pharmaco vigilance 5) Medical Coding 6) CDISC/SDTM 7) SAS-Clinical To enroll in any of these courses and packages tailored to to your needs contact at any by emailing Lara Clinical Research, Ameerpet Hyderabad Calling Pharmacy professionals, Medicine professionals, Life science Studnets, IT Students Training will be conducted in Hyderabad Ph: 040-,