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23 feb 2012 IIBA Pharma/Biotech SIG Webinar
 

23 feb 2012 IIBA Pharma/Biotech SIG Webinar

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Sanjay Sahoo, MedImmune, presents The Role of a Business or Systems Analyst in the Clinical / Medical / Regulatory Space at the February 23, 2012 IIBA Pharma/Biotech Special Interest Group Webinar.

Sanjay Sahoo, MedImmune, presents The Role of a Business or Systems Analyst in the Clinical / Medical / Regulatory Space at the February 23, 2012 IIBA Pharma/Biotech Special Interest Group Webinar.

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    23 feb 2012 IIBA Pharma/Biotech SIG Webinar 23 feb 2012 IIBA Pharma/Biotech SIG Webinar Presentation Transcript

    • IIBA® Pharma/Biotech SIG Monthly Webinar The Role of a Business or Cover this area with a Systems Analyst picture related to your in presentation. It can be humorous. Clinical/Medical/ Regulatory Make sure you look at the Notes Pages for more information 23 Feb 2012 about how to use the template. Sanjay Sahoo, MedImmune © International Institute of Business Analysis
    • IIBA® Pharma/Biotech SIG Monthly Webinar The Role of a Business or Cover this area with a Systems Analyst picture related to your in presentation. It can be humorous. Clinical/Medical/ Regulatory Make sure you look at the Notes Pages for more information 23 Feb 2012 about how to use the template. Sanjay Sahoo, MedImmune © International Institute of Business Analysis
    • Agenda• Welcome & Announcements• The Role of a Business or Systems Analyst in Clinical/Medical/Regulatory  Sanjay Sahoo, MedImmune• Q&A © International Institute of Business Analysis
    • Welcome• Speakers  Sanjay Sahoo, MedImmune• IIBA Pharma/Biotech SIG Staff  Host – Michael Calluori (Sanofi), VP of the Community  Question Moderator – Carol Scalice (Pfizer), President  Webinar Administrator – Matt St. Louis (Pfizer), VP of Marketing © International Institute of Business Analysis
    • Join the Community• Starting April 2012  Closed webinars (not public)  Must be an IIBA® member• Join the Community  http://community.iiba.org/pharmabiotechsig  No additional cost © International Institute of Business Analysis
    • Certification Credit• PDUs/CDUs for SIG Events  1 webinar = 1 CDU  Recertification only * As per IIBA® Certification team * © International Institute of Business Analysis
    • Volunteer• Open Interim Board Positions  VP of Communications  VP of Event Planning• Filled Interim Board Positions  VP of Sponsorship – Leah Estberg, USDA APHIS Veterinary Services  VP of Technology – Jim Blay, Covance © International Institute of Business Analysis
    • Who to ContactPlease contact one of the acting board members listed below: Carol Scalice: President Carol.Scalice@pfizer.com Mike Horn: VP, Membership michael.horn@astrazeneca.com Matthew St. Louis: VP, Marketing matthew.v.st.louis@pfizer.com Michael Calluori: VP, Community Michael.Calluori@sanofi-aventis.com © International Institute of Business Analysis
    • Next Webinar• “What about ...? What I wished I had asked the regulatory and testing people.”  Griffin Jones, Congruent Compliance  Monday, March 19th, 12-1p  Register Today  https://www2.gotomeeting.com/register/823957186• Call for Speakers  Send us your topic ideas and submissions today! © International Institute of Business Analysis
    • The Role of the BA or Systems Analyst inClinical/Medical/Regulatory• Speaker  Sanjay Sahoo  Business Analyst, MedImmune• Q&A  “Raise Hand”  Chat Window © International Institute of Business Analysis
    • The Role of a Business/System Analyst in Clinical/ Learning Objectives: I. Basic understanding of BA/SA role II. Is there a boundary for BA/SA role by industry? III. How pharma/bio-tech BA/SA roles differentiate from other industry? IV. Does BA/SA require any special skill sets? V. Does prior experience in pharma/bio-tech matters? VI. Understand birds eye view of clinical drug development process VII. How clinical/medical/regulatory systems are aligned with the process? VIII. What are the industry standards? IX. How to be informed about pharma/bio-tech industry? X. What are next steps for BA/SA role in pharma/bio-tech industry?
    • About Me Sanjay Kumar is a Senior Business/System Analyst at MedImmune LLC. (A subsidiary of AstraZeneca PLC)., where he plays a role of Sr. IS/IT Specialist of the Clinical/Medical/Regulatory domain. Prior to joining to MedImmune, he had an extensive experience with Health Informatics Technology (HIT) which includes implementation, design, business analysis, systems analysis and IT strategy planning for US Government agencies such as National Institute of Health, National Cancer Institutes, Division of Aids (NIAID) and Pharmaceutical/Bio-Tech companies. Overall Mr. Sanjay has 15 years of experience in the bio-informatics field providing enterprise solutions for pharma/bio-tech industry. He had a recent success implementing e-Clinical program at MedImmune LLC. He has a strong educational background, includes Bachelors of Science in Physics, Master of Science in Computer Science, and Master in Business Administration from Johns Hopkins University, USA.” © International Institute of Business Analysis
    • Business/System Analysis Role• Works in the context of an organization• Understand Business People Process• Understand Business Processes BA/SA Role• Determine process improvement• Define the business/functional requirements• Understand IT eco Systems Technology• Implement by assisting Technical TeamBusiness/System Analyst role is the techniques used to work as a liaison amongorganization stakeholders in order to understandpeople, processes, technology, regulations, policies, and work instructions foroperations of an organization, and propose best approaches or solutions thatenable organizations to achieve organizational goals © International Institute of Business Analysis
    • Industry Boundary?Answer is NO…Business/Systems analyst position for healthcare domain, there are lotof expectations from the business/systems analyst candidate.Healthcare domain is a complex domain and requires a good workingbackground in the industry to know in detail its business process andinternal workings. © International Institute of Business Analysis
    • How BA/SA role differentiate? General BA/SA Role Clinical/Medical/Regulatory BA/SA• Gather Requirement • Performs all as described in• Perform Systems Analysis General BA/SA role PLUS below• Manage Team i.e. technical, • Work with Doctors, RN, Scientists, creative, and production, Lab Technician external vendor and contractors • Understand GXP includes GCP• Scope the requirement guidelines• Align to the budget • Understand Frequent Changes in Regulatory Agencies Rules• Direct development lifecycle from inception to completion • Required a depth knowledge on Health Informatics - Mandatory• Assist Programming team • Attend Conferences, Training• Use best practice ensuring frequently consistency and stability • Need to have people skills• Develop wireframe or demo application for concept • Negotiation and Agreements © International Institute of Business Analysis
    • Special Skill Sets Required• Requirement Methodologies• Testing Methods – Regression, Unit Test, Blackbox• Software Development Framework - SDLC• Clinical Trial procedures and terminology• Knowledge in tools like SAS, eCTMS, EDC, IVRS, Safety System• Knowledge of GXP Assessment• Regulatory Agencies Guidelines• Knowledge of 21CFR Part 11• Industry Standards like ICH, MedDRA, CTC, CDISC, BRIDGE, HL7, LOINC• XML with eSubmission processes © International Institute of Business Analysis
    • Prior Experience Required?• Both “Yes” and “No”• If “Yes” – easier to adapt to the environment quickly• Else required extensive training• Both cases you need to be open to adapt the complex world © International Institute of Business Analysis
    • Clinical Drug Development Process File IND/CTA File BLA/NDA/sNDA With FDA With FDA Phase II Phase III Drug Discovery Pre-Clinical Phase 0 Phase I ~100-500 Human 1000 and more Phase IV ~5000-10000 Compounds Animal Trial ~10-15 ~20-100 Trial 1 Compound Human Trial Post Marketing ~250 Compounds Human Trial Human Trial ~5 Compounds) 1 Compound R&D Space Clinical Development Space Pharmacovigilance Space ~ 14 years in total to market NDA – New Drug Application BLA – Biologic License Agreement IND – Investigational New Drug Application IDE – Investigational Device Exception sNDA – Supplemental New Drug Application Safety CTA – Clinical Trial Authorization File in EU Quality EfficacyDisclaimer – The use of images in this presentation are abstracted from www.google.com. The purpose of these images are ONLY for learning/academic. This is NOT for anycommercial or marketing use. © International Institute of Business Analysis
    • List of Systems for Clinical Space CLINICAL REGULATORY MEDICALClinical Forecasting System Central Document Management Information Request ManagementClinical Project Planning eSubmission Planning & Tracking Information Request Content ManagementProtocol Authoring Tool Commitment Tracking Reprint TrackingClinical Trial Management System Submission Publishing Compliance Reporting ManagementElectronic Data Capture Product Registration Management ePublication ManagementInteractive Voice Recognition Tool Correspondence Tracking Grant ManagementPaper Based Trial Product Complaints Tracking Investigator Initiated Trial MgmtStatistical Programming (SAS) eCTD Reviewer Key Opinion Leader ManagementElectronic Trial Master File Business Event Tracking Medical Library ManagementClinical Trial Transparency Product Detail Management Mobile Request ManagementPatient Safety System Scientific Communication Tracking SafetyDrug Supply ManagementCentral Medical Coding System QualityInvestigator Management Tool EfficacyeClinical Data HubCentral Study Designer © International Institute of Business Analysis
    • Industry Standards Standards Regulations Guidelines Referencing Dictionaries Messaging Coding Metadata21CFR 11 (Audit) ICH E2A (Efficacy Guidelines) CDISC (Clinical Data Standard) MedDRA (Med Coding ISO/IEC 11179 (Information HL7 + HL7 CVX (vaccine form) Technology - Metadata registries (MDR)45 CFR164 (Security) ICH E2B (Data Transfer) LOINC (Lab Code) WHO-ART (Rational Coding AE) LOINC (Lab Code)HIPAA (Patient Info) ICH E2BM (Clinical Safety Data DICOM (Digital Imaging and WHO Drug NDF-RT (National Drug File Management) Comm) Reference Terminology)Section 508 (Disability) ICH E5 (Ethnic Factors in the HL7 (Health Level 7) SNOMED-CT Systemized EVS (NCI Enterprise Vocabulary Acceptability of Foreign Clinical Nomenclature of Medicine - Clinical Services) Data) Term)FDAAA (Trial Transparency) ICH E6 (GCP) NDC (National Drug Code) OMB Directive 15 (Race and Ethnic Standard) eCTD (Electronic Submission)EudraCT ICH M1 (MedDRA MSSO) ISO 639 (Language) CTC AE (Common Toxicity Criteria Adverse Event) ICH M2 (MedDRA eCTD Spec) ISO 3166 (Code name for Countries) © International Institute of Business Analysis
    • How to be informed?• Be part of IIBA Pharma/Biotech SIG www.iiba.org• Enroll to DIA www.diahome.org• Subscribe clinical trial magazines• Be a member of HIMSS group www.himss.org• The best way to have friends from health industry © International Institute of Business Analysis
    • Next Step for a BA/SA role• Project Lead• Project Manager• Subject Matter Expert• Process Engineer• Process Architect• Enterprise Process Engineer• Business Manager• System Director• Health Informatics Technology Consultant © International Institute of Business Analysis
    • Q/A Thank you If you have any question, please contact me at sanjay05m@gmail.com © International Institute of Business Analysis
    • Thank you for attending!• Next Webinar  “What about ...? What I wished I had asked the regulatory and testing people.” - Griffin Jones, Congruent Compliance  Monday, March 19th, 12-1p  Register: https://www2.gotomeeting.com/register/823957186• Contact the President: Carol.Scalice@pfizer.com  Topic ideas and speaker submissions  Volunteering – Communications, Event Planning  Joining the Community © International Institute of Business Analysis