1 / 20

Pharmaceutical courses and training institute, Thane

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.

raajgprac2013
Download Presentation

Pharmaceutical courses and training institute, Thane

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 Professionals 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 • 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, 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 • 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 DRUGSAFETY 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

More Related