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Raaj gprac courses

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We at Raaj GPRAC (Global Pharma Regulatory Affairs Consultants) in Thane, India offer pharma consulting, regulatory affairs services. We also conduct various workshops and seminars on pharma courses. …

We at Raaj GPRAC (Global Pharma Regulatory Affairs Consultants) in Thane, India offer pharma consulting, regulatory affairs services. We also conduct various workshops and seminars on pharma courses. Our Pharmaceutical Education arm conducts 6 months diploma courses in CTD/eCTD and regulatory affairs, also we conduct fast track pharma courses, distance learning programs for working professional and part time courses pertaining to Pharma and Biotech industry for students and working professionals.

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  • 1. Raaj GPRAC India’s Best Training Institute, Offers Advanced PGDiplomas through Various Fast Track training and Distance Learningprogrammes in•Regulatory Affairs•CTD/eCTD•Quality Assurance/Quality Management•Pharma Documentation•Clinical Research•Pharmacovigilance•Patent Laws & Procedures•Patent Agent Exam PreparationFor Pharma/Biotech/Life Sciences working Professionals & StudentsEligibility: Freshers like B.Pharm/M.Pharm/ PhD/B.Tech/M.Tech/ B.Sc/M.Sc/Biotech/ BAMS/BHMS /BDS/MDS/MBBS/MD and RA, QA, Clinical 1Professionals Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 2. We have our expertise in following courses: Category I: 6m Advanced PG Diploma in Drug Regulatory Affairs (Formulations) Category II: 6m Advanced PG Diploma in Drug Regulatory Affairs (API) Category III: 4m Certification course in CTD and eCTD in Formulation Category IV: 4m Certification course in CTD and eCTD in API Category V: 4m Certification course in Quality Assurance & Quality Management Category VI: 4m Certification course in Clinical Research Category VII: 3m Certification course in Pharmaceutical Documentation Category VIII: 3m Certification Course in Pharmacovigilance Category IX: 6m Advanced PG Diploma in Patents Laws and Procedures 2 Category X: 3m Patent Agent Exam Preparation Course Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 3. What you will learn undereach category of course? 3 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 4. Category I: 6m Advanced PG Diploma inDrug Regulatory Affairs (Formulations) 4 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 5. Category I: 6m Advanced PG Diploma in Drug Regulatory Affairs (Formulations) Salient Features : Understanding Regulatory Affairs profession, its role & importance General Overview of the Pharmaceutical Industry, its functioning, role of various departments Overview of Worldwide Regulatory Agencies Drug Development Process with Clinical Phases I, II, III & IV Drug Registration in Regulated Markets like USFDA, EUROPE, Canada etc Drug Registration with Rest of the World (RoW) like ASEAN Countries, Latin America, Middle East Countries, etc Understanding of QbD and ICH topics from Q1, Q2, Q3… to Q11, cGMP, GLP, GCP, etc PDR (Product Development Report) and Writing as per ICH Q8 Details of CTD modules I, II, III, IV & V and Understanding core concept of eCTD. Electronic Submissions [21 CFR Part 11] NeeS, eCTD, ESG, etc 5 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 6. Category II: 6m Advanced PG Diploma in Drug Regulatory Affairs (API) 6 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 7. Category II: 6m Advanced PG Diploma in Drug Regulatory Affairs (API) Salient Features : Understanding Regulatory Affairs profession, its role & importance General Overview of the Pharmaceutical Industry, its functioning, role of various departments API Characterization & Impurities Drug Substance Registration in Regulated Markets like USFDA, EUROPE, etc Drug Substance Registration with Rest of the World (RoW) CTD Format for DMF Certificate Of Suitability (CoS), etc Electronic Submissions [21 CFR Part 11] NeeS, eCTD, ESG, etc 7 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 8. Category III/IV: 4m Certification course in CTD and eCTD in Formulation / API eCTD 8 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 9. Category III/IV: 4m Certification course in CTD and eCTD in Formulation / API Salient Features : Understanding Regulatory Affairs profession, its role & importance General Overview of the Pharmaceutical Industry, its functioning, role of various departments Overview of ICH guidelines Organization of CTD Overview of eCTD eCTD Submission for USFDA eCTD Submission for European Union Filings Differences between US & Europe eCTD Submissions Electronic Submissions [21 CFR Part 11] NeeS, eCTD with xml backbone, etc 9 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 10. Category V: 4m Certification course inQuality Assurance & Quality Management 10 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 11. Category V: 4m Certification course in Quality Assurance & Quality Management Salient Features : Understanding Quality Assurance/ Quality Control profession, its role & importance General Overview of the Pharmaceutical Industry, its functioning, role of various departments Overview of GLP, GMP Introduction of ICH & Emphasis on ICH Q7 –Validations like Process, Water system, Cleaning, HVAC, Sterile Procedures, Computer Systems, etc GMP-Schedule M of D & C Act, WHO requirements, USFDA guidelines, Documentation requirements QA Aspects on Complaints, Recalls, Change Control, Deviation Control, Vendor Approvals, Recovery, Annual Product review, etc Audit Preparations- GMP Compliance to International Regulatory Standards such as WHO, USFDA, EDQM, MHRA, FDA, etc Vendor Auditing Effective SOP Writing in a GMP environment, Good Documentation Practices, etc 11 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 12. Category VI: 4m Certification course in Clinical Research 12 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 13. Category VI: 4m Certification course in Clinical Research Salient Features : Clinical Research profession, its role & importance General Overview of the Pharmaceutical Industry, CRO’s its functioning, role of various functions like Clinical Research associate, Clinical Team Leader, Project Manager, Manager-Clinical Trial Supplies, QA Manager, Data Manager, Medical & Regulatory Affairs Manager, Biostaticians, Data Entry Operator, Head of Clinical Operations, etc Drug Development Process including Clinical trials Animal studies in drug development, Regulatory process in preclinical studies GCP as per ICH E6 Fundamentals of Monitoring Clinical Trials Project management along with Risk Management Clinical Safety & Pharmacovigilance-AE, ADR, SAE, UADR, etc 13 With additionalCopyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com information on Clinical Data Management
  • 14. Category VII: 3m Certification course in Pharmaceutical Documentation 14 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 15. Category VII: 3m Certification course in Pharmaceutical Documentation Salient Features : Understanding Pharma Documentation profession, Quality Management system (QMS) SOPs, Protocols, Master Formula plan, Manufacturing Records, Packing Records, Batch Records, BMR, Specifications, Warehousing, Sampling, etc Training & Qualifications of Personnel Validation Documentation Documentation Control Product Development Documentation Specification of Drug Product Stability testing Documentation 15 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 16. Category VIII: 3m Certification Course in Pharmacovigilance 16 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 17. Category VIII: 3m Certification Course in Pharmacovigilance Salient Features : Introduction & Objectives of Pharmacovigilance ADR –Classification & types, PMS ICH Guidelines with respect to Quality & safety Pharmacovigilance Methods Wings & Role of Pharmacovigilance Scope of Pharmacovigilance Signal Detection & Analysis Good PV Practices Periodic Safety Updates (PSUR) 17 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 18. Category IX: 6m Advanced PG Diploma in Patents Laws and Procedures 18 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 19. Category IX: 6m Advanced PG Diploma in Patents Laws and Procedures Salient Features : Overview of the Pharmaceutical Industry and Importance of IPR & Patents International Treaties/ Conventions on IPR Patents Laws and Procedures for Indian patents USPTO, Title 35 CFR European Patent regime Business Model Patents- Biotech Patents Software Patents Patentability of Life Forms Many Case Studies on Patent Laws 19 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com
  • 20. THANK YOU! 20Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com

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