Pharmaceutical courses and training institute, Thane - PowerPoint PPT Presentation

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Pharmaceutical courses and training institute, Thane

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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. 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. – PowerPoint PPT presentation

Number of Views:761
Updated: 27 November 2012
Slides: 21
Provided by: raajgprac2013

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Title: Pharmaceutical courses and training institute, Thane


1
  • Raaj GPRAC Indias 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
    Professionals

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
  • Category X 3m Patent Agent Exam Preparation
    Course

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
3
  • What you will learn under
  • each category of course?

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
4
  • Category I 6m Advanced PG Diploma in
  • Drug Regulatory Affairs (Formulations)

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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
6
  • Category II 6m Advanced PG Diploma in
  • Drug Regulatory Affairs (API)

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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
8
  • Category III/IV 4m Certification course in
  • CTD and eCTD in Formulation / API

eCTD
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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
10
  • Category V 4m Certification course in
  • Quality Assurance Quality Management

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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
12
  • Category VI 4m Certification course in
  • Clinical Research

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,
    CROs 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
  • With additional information on Clinical Data
    Management

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
14
  • Category VII 3m Certification course in
    Pharmaceutical Documentation

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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
16
  • Category VIII 3m Certification Course in
    Pharmacovigilance

DRUG SAFETY
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)

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
18
  • Category IX 6m Advanced PG Diploma in
  • Patents Laws and Procedures

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

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
20
  • THANK YOU!

Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
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