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.

1. Raaj GPRAC India’s Best Training Institute, Offers Advanced PG
Diplomas through Various Fast Track training and Distance Learning
programmes in
•Regulatory Affairs
•CTD/eCTD
•Quality Assurance/Quality Management
•Pharma Documentation
•Clinical Research
•Pharmacovigilance
•Patent Laws & Procedures
•Patent Agent Exam Preparation
For Pharma/Biotech/Life Sciences working Professionals & Students
Eligibility: 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 1
Professionals
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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
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 Category X: 3m Patent Agent Exam Preparation Course
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3. What you will learn under
each category of course?
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4. Category I: 6m Advanced PG Diploma in
Drug Regulatory Affairs (Formulations)
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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
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6. Category II: 6m Advanced PG Diploma in
Drug Regulatory Affairs (API)
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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
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8. Category III/IV: 4m Certification course in
CTD and eCTD in Formulation / API
eCTD
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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
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10. Category V: 4m Certification course in
Quality Assurance & Quality Management
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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
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12. Category VI: 4m Certification course in
Clinical Research
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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
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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
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16. Category VIII: 3m Certification Course in
Pharmacovigilance
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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)
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18. Category IX: 6m Advanced PG Diploma in
Patents Laws and Procedures
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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
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20. THANK YOU!
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