+91-98 455 710 46 | info@nckpharma.com
Sign In
|Sign Up
Please sign in first
Not a member?
Please simply create an account before buying/booking any courses.
Create an account for free!
- Home
- About Us
- NCK services
- Course List
- Admission
- Course Quick Glance
- Features of Online Courses
- Course Catalogue
- Course Application form
- Admission Notification & Special Offers
- Frequently asked question related to KPE courses
- Prospect Identification Process
- Final Examination Registration
- How to change / reset password?
- Course Upgrade
- Verify Course Certificate
- Request for Course Completion Certificate
- Contact
Comparison of Drug Regulatory Affairs Courses
| Conetnt of DRA program at www.nckpharma.com | Fundamental Training | Certificate Course | Advance Diploma | Executive Diploma |
|---|---|---|---|---|
| Course Code | KPE-C-054 | KPE-C-046 | KPE-C-003 | KPE-C-103 |
| Duration | 1 Week | 1 Month | 1 Year | 1 Year |
| Downloaded e-modules | 1 | 5 | 18 | 22 |
| Course Completion Certificate | Yes | Yes | Yes | Yes |
| Course Gradation Certificate | Yes | Yes | Yes | Yes |
| Add on Certification Course | NONE | NONE | NONE | Free 1 - one week & 1 - one month certificate course |
| Course Upgrade | NONE | to Advance / Executive DRA program | To Executive DRA program | NONE |
| FUNDAMENTAL OF DRUG DISCOVERY, DEVELOPMENT | - | - | - | - |
| Introduction to R&D Process & drug discovery | YES | YES | YES | YES |
| Investigational New Drug Application | YES | YES | YES | YES |
| New Drug Application (NDA) | YES | YES | YES | YES |
| Basic concept and understanding of the Generic Drug | YES | YES | YES | YES |
| Abbreviated New Drug Application (ANDA) | YES | YES | YES | YES |
| Complete Response Letter (CRL) and Action plan for effective management of CRL | YES | YES | YES | YES |
| Handling of orange book | YES | YES | YES | YES |
| USFDA Expedited Programs (Detailed Understanding) | YES | YES | YES | YES |
| 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA | YES | YES | YES | YES |
| Concept of Authorized Generics: Key Understanding | YES | YES | YES | YES |
| Concept of Exploratory IND | YES | YES | YES | YES |
| Patents Vs. exclusivity | YES | YES | YES | YES |
| Orphan Drug Designation | YES | YES | YES | YES |
| Advance Learning on 505B2 Pathway | YES | YES | YES | YES |
| Chemistry, Manufacturing & Controls - Fundamental Understanding | YES | YES | YES | YES |
| Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity | YES | YES | YES | YES |
| Review on drug discovery and development | YES | YES | YES | YES |
| Emergency Use Authorization (EUA) | YES | YES | YES | YES |
| CLINICAL TRIAL / RESEARCH - FUNDAMENTAL | ||||
| Clinical Trial Detailed Study | NO | YES | YES | YES |
| Clinical Trial Protocol Writing | NO | YES | YES | YES |
| Ethics in Clinical Research | NO | YES | YES | YES |
| Informed Consent | NO | YES | YES | YES |
| FDA forms and How to fill FDA forms | NO | YES | YES | YES |
| Strategic Discussion: PreIND, EOP1, EOP2 - What to expect ! | NO | YES | YES | YES |
| IP Management | - | - | - | - |
| USPTO - Introduction | NO | YES | YES | YES |
| Patent - Fundamental Concepts | NO | YES | YES | YES |
| Patent Application Process - USPTO | NO | YES | YES | YES |
| Trademark Search and Registration in US | NO | YES | YES | YES |
| Steps Know How & Key Points - Patent Application | NO | YES | YES | YES |
| IPR - Patent Grant and Handling Process | NO | YES | YES | YES |
| Patent Searching | NO | YES | YES | YES |
| Trademark - Practical on Trademark searching and Registration | NO | YES | YES | YES |
| Trademark Search assignment | NO | YES | YES | YES |
| Fundamental Understanding of Patent, Trademark Licensing and related terminology | NO | YES | YES | YES |
| REGULATORY STRATEGIC / PORTFOLIO MANAGEMENT PLANNING | - | - | - | - |
| Regulatory Strategies in different phases of Clinical Trial | NO | YES | YES | YES |
| Advance study on Para IV Filing | NO | YES | YES | YES |
| Para IV Notice | NO | YES | YES | YES |
| Evergreening - Patent Life Extension Strategies | NO | YES | YES | YES |
| Pay For Delay Strategy | NO | YES | YES | YES |
| REMS Strategic Planning | NO | YES | YES | YES |
| Compulsory Licensing | NO | YES | YES | YES |
| Technology Licensing | NO | YES | YES | YES |
| In-Licensing Vs. Out licensing | NO | YES | YES | YES |
| LOE Strategies for Innovator Brands with case study | NO | YES | YES | YES |
| Paediatric Exclusivity and Paediatric Study Plan Development | NO | YES | YES | YES |
| Drug Re-purposing | NO | YES | YES | YES |
| Practical Queries on different USFDA application and Filing | NO | YES | YES | YES |
| Publication Management from Regulatory perspective | NO | YES | YES | YES |
| Juxtapid Case Study | NO | YES | YES | YES |
| New Indication Approval Process and Promotion | NO | YES | YES | YES |
| OTC Switch | NO | YES | YES | YES |
| Practical Case Study in Rx to OTC Switch | NO | YES | YES | YES |
| Good Manufacturing Practices | - | - | - | - |
| Definition of GMP | NO | YES | YES | YES |
| Certification Pharmaceutical Companies / Plants | NO | YES | YES | YES |
| Introduction to Good Manufacturing Practices | NO | YES | YES | YES |
| Premises & Plant Layout Designing | NO | YES | YES | YES |
| Sanitation and Hygiene | NO | YES | YES | YES |
| Equipment | NO | YES | YES | YES |
| Production Modules | NO | YES | YES | YES |
| GMP Documentation | NO | YES | YES | YES |
| Quality Control | NO | YES | YES | YES |
| Handling of Product Complaint | NO | YES | YES | YES |
| GMP Storage | NO | YES | YES | YES |
| ISO and ISO Audits | NO | YES | YES | YES |
| Pharmaceutical SOPs | NO | YES | YES | YES |
| SOP Automation | NO | YES | YES | YES |
| Submission Dossier | - | - | - | - |
| Advance Practical Training on Dossier Preparation focusing on drug registration in export countries | NO | YES | YES | YES |
| Introduction to Common Technical Document (CTD) | NO | YES | YES | YES |
| CMC Dossier & Compliance Management | NO | YES | YES | YES |
| Key Consideration for Drug Master File Preparation and Submission | NO | YES | YES | YES |
| Practical Understanding on Drug Master File Preparation and Submission | NO | YES | YES | YES |
| Site Master File - Detailed Understanding | NO | YES | YES | YES |
| DMF Completeness Assessment | NO | YES | YES | YES |
| Drug Master File - Fees | NO | YES | YES | YES |
| Drug Master File - Global Perspective [Across Different Regions] | NO | YES | YES | YES |
| Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study | NO | YES | YES | YES |
| Black Box Warning | NO | NO | YES | YES |
| Importance of effective dossier management | NO | NO | YES | YES |
| Deficiencies observed in CTD Dossiers | NO | NO | YES | YES |
| Certificate of Analysis | NO | NO | YES | YES |
| Detailed Understanding on ANDA Submission Dossier | NO | NO | YES | YES |
| Detailed Understanding on ANDA Fees | NO | NO | YES | YES |
| 505(b)(2) VS. Suitability Petition : Case Based Learning | NO | NO | YES | YES |
| NCE Vs. 505b2 application - Case Based Learning | NO | NO | YES | YES |
| FTF - 180 Days Exclusivity - Case Based Learning | NO | NO | YES | YES |
| Classic case study of the 505b2 filing | NO | NO | YES | YES |
| Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning | NO | NO | YES | YES |
| Prior Approval Submission | NO | NO | YES | YES |
| BIOPHARMACEUTICAL REGULATION [INNOVATOR & BIOSIMILAR] | - | - | - | - |
| Introduction : Biopharmaceuticals | NO | NO | YES | YES |
| Classification of Biopharmaceutical | NO | NO | YES | YES |
| Introduction to Biosimilar | NO | NO | YES | YES |
| Chemical Drugs Vs. Biologic Drugs | NO | NO | YES | YES |
| Purple Book: Handling of Purple Book | NO | NO | YES | YES |
| Principle of Naming of Biologics | NO | NO | YES | YES |
| Current Trends in Biopharmaceutical Market | NO | NO | YES | YES |
| Present Encouraging Factors for Biopharmaceutical Industry | NO | NO | YES | YES |
| Complexity of biopharma supply chain and operations | NO | NO | YES | YES |
| Biopharma Market Segmentation | NO | NO | YES | YES |
| Blockbuster Biologic - Classifications, Indications, Global Sales | NO | NO | YES | YES |
| Recombinant protein | NO | NO | YES | YES |
| Monoclonal Antibodies | NO | NO | YES | YES |
| Synthetic Immunomodulators | NO | NO | YES | YES |
| Production of Monoclonal Antibodies | NO | NO | YES | YES |
| Cytokines | NO | NO | YES | YES |
| Interferon | NO | NO | YES | YES |
| Erythropoiesis-stimulating agent | NO | NO | YES | YES |
| Biological Licensing Application (BLA) | NO | NO | YES | YES |
| Biosimilar Approval process | NO | NO | YES | YES |
| Vaccine development and approval Process | NO | NO | YES | YES |
| Review : 351(a) vs. 351(k) pathway | NO | NO | YES | YES |
| Biosimilar Development Process | NO | NO | YES | YES |
| Strategic Consideration for Biosimilar Development | NO | NO | YES | YES |
| Bio-Manufacturing Process Information | NO | NO | YES | YES |
| USFDA WARNING LETTER & CAPA | - | - | - | - |
| Advance Training on Data Integrity | ALCOA principle | Consequences | Management | Audit Trail | NO | NO | YES | YES |
| Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter | NO | NO | YES | YES |
| Handling of warning letter | NO | NO | YES | YES |
| Case Study: Warning Letter | NO | NO | YES | YES |
| CAPA - Importance & Principle | NO | NO | YES | YES |
| DRUG REGISTRATION IN EUROPEAN COUNTRIES | - | - | - | - |
| Introduction EU Drug Regulatory Affairs | NO | NO | YES | YES |
| Orientation to European Countries and National Regulatory Bodies | NO | NO | YES | YES |
| EU Drug Discovery Development to Commercialization (Step By Step) | NO | NO | YES | YES |
| Overview of EU Regulation | NO | NO | YES | YES |
| EMA and EMA Authorisation Process | NO | NO | YES | YES |
| EU MA Application Types and Strategic Planning | NO | NO | YES | YES |
| EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure | NO | NO | YES | YES |
| The 'sunset clause' for marketing authorisations of pharmaceuticals | NO | NO | YES | YES |
| EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application. | NO | NO | YES | YES |
| Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products | NO | NO | YES | YES |
| Data Exclusivity and Market Protection - 8+2+1 Formulae | NO | NO | YES | YES |
| EU Orphan Drug Regulation and MA Procedure | NO | NO | YES | YES |
| Conditional marketing authorisation | NO | NO | YES | YES |
| Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) | NO | NO | YES | YES |
| Compassionate use | NO | NO | YES | YES |
| Sunset clause | NO | NO | YES | YES |
| MHRA UK regulation | NO | NO | YES | YES |
| Accelerated Assessment by European Medicine Agency | NO | NO | YES | YES |
| Master Data Maintenance by European Medicine Agency | NO | NO | YES | YES |
| Access to Case study directory | NO | NO | YES | YES |
| 48 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests | NO | NO | YES | YES |
| Access to Case study directory | NO | NO | YES | YES |
| Drug Registration and Regulation in China | ||||
| Introduction to CFDA | NO | NO | NO | YES |
| Drug Registration Pathway | NO | NO | NO | YES |
| Clinical Trial Review Process | NO | NO | NO | YES |
| Documentation for new drug registration | NO | NO | NO | YES |
| Review Timeline | NO | NO | NO | YES |
| Safety Reporting | NO | NO | NO | YES |
| Investigational products - labelling, packaging and product management aspects | NO | NO | NO | YES |
| Import and export of pharmaceutical from China | NO | NO | NO | YES |
| COUNTRY PROFILES AND DRUG REGULATION & REGISTRATION IN LATIN AMERICAN COUNTRIES | - | - | - | - |
| Regions in Pharma Business : Common Terminologies | NO | NO | NO | YES |
| Argentina Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Bolivia Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Brazil Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Chile Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Colombia Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Mexico Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Peru Pharmaceutical Market and Drug Registration Process | NO | NO | NO | YES |
| Drug Registration in El Salvador | NO | NO | NO | YES |
| Drug Registration in Paraguay | NO | NO | NO | YES |
| Drug Registration in Venezuela | NO | NO | NO | YES |
| Drug Registration Requirements in Other Latam Countries | NO | NO | NO | YES |
| Drug Registration Requirements Comparison of all LATAM countries | NO | NO | NO | YES |
| Comparison of LATAM regulatory requirements Vs. ASEAN, GCC, CDSCO, EU, US | NO | NO | NO | YES |
| DRUG REGISTRATION IN ASEAN COUNTRIES | - | - | - | - |
| ASEAN Drug Regulatory Affairs | NO | NO | NO | YES |
| ASEAN Geography | NO | NO | NO | YES |
| Drug Registration in Brunei | NO | NO | NO | YES |
| Drug Registration in Malaysia | NO | NO | NO | YES |
| Drug Registration in Cambodia | NO | NO | NO | YES |
| Drug Registration in Myanmar | NO | NO | NO | YES |
| Drug Registration in Philippines | NO | NO | NO | YES |
| Drug Registration in Singapore | NO | NO | NO | YES |
| Drug Registration and Regulation in Middle East and GCC countries | - | - | - | - |
| GCC and Middle East Pharma Market | NO | NO | NO | YES |
| Export in GCC countries and Other Middle East Countries | NO | NO | NO | YES |
| GCC Registration Procedure | NO | NO | NO | YES |
| Drug Registration in Saudi Arabia | NO | NO | NO | YES |
| Documentation Required for the GCC countries | NO | NO | NO | YES |
| Drug Registration in Bahrain, | NO | NO | NO | YES |
| Drug Registration in UAE | NO | NO | NO | YES |
| Drug Registration in Kuwait | NO | NO | NO | YES |
| Drug Registration in Qatar | NO | NO | NO | YES |
| Drug Registration in Oman | NO | NO | NO | YES |
| Drug Registration in Iran | NO | NO | NO | YES |
| Drug Registration in Iraq | NO | NO | NO | YES |
| Drug Registration in Israel | NO | NO | NO | YES |
| Drug Registration in Jordon | NO | NO | NO | YES |
| Drug Registration in Lebanon | NO | NO | NO | YES |
| Drug Registration in Libya | NO | NO | NO | YES |
| Drug Registration in Palestine | NO | NO | NO | YES |
| Drug Registration in Sudan | NO | NO | NO | YES |
| Drug Registration in Syria | NO | NO | NO | YES |
| Drug Registration in Yemen | NO | NO | NO | YES |
| Drug Registration in Eurasian Economical Union (EEU) & Commonwealth of Independent States (CIS) countries | - | - | - | - |
| Drug Discovery & Development fundamental | NO | NO | NO | YES |
| Clinical Trial Regulation | NO | NO | NO | YES |
| Drug Registration requirements | NO | NO | NO | YES |
| Dossier Preparation new product submission | NO | NO | NO | YES |
| Dossier for re-registration | NO | NO | NO | YES |
| Dossier variation guideline | NO | NO | NO | YES |
| Drug Registration and Regulation in India | - | - | - | - |
| Drug Regulation in India - CDSCO | NO | NO | NO | YES |
| National Pharmaceutical Pricing Authority | NO | NO | NO | YES |
| Drug Price Regulation in India | NO | NO | NO | YES |
| Drug Registration in India - Practical understanding drug registration process in CDSCO | NO | NO | NO | YES |
| Drug Price Control Order | NO | NO | NO | YES |
| New Drug Approval Process in India | NO | NO | NO | YES |
| Drug Registration and Regulation in Africa | - | - | - | - |
| Overview - African Continent | NO | NO | NO | YES |
| Insight on African Pharma Market | NO | NO | NO | YES |
| Drug Registration - African medicines regulatory (Overall Understanding) | NO | NO | NO | YES |
| Basic Export Requirement for African Countries | NO | NO | NO | YES |
| Export Documentations & Important Concepts | NO | NO | NO | YES |
| Drug Registration and Regulation in Nigeria | NO | NO | NO | YES |
| Drug Registration and Regulation in Algeria | NO | NO | NO | YES |
| Drug Registration and Regulation in Ethiopia | NO | NO | NO | YES |
| Drug Registration and Regulation in Kenya | NO | NO | NO | YES |
| Drug Registration and Regulation in Egypt | NO | NO | NO | YES |
| Drug Registration and Regulation in Ghana | NO | NO | NO | YES |
| Drug Registration and Regulation in Botswana | NO | NO | NO | YES |
| Drug Registration and Regulation in South Africa | NO | NO | NO | YES |
| Drug Registration and Regulation in Zambia | NO | NO | NO | YES |
| Drug Registration and Regulation in Sudan | NO | NO | NO | YES |
| Drug Registration and Regulation in Namibia | NO | NO | NO | YES |
| Drug Registration and Regulation in Tanzania | NO | NO | NO | YES |
| Drug Registration and Regulation in Senegal | NO | NO | NO | YES |
| Drug Registration and Regulation in Zimbabwe | NO | NO | NO | YES |
| Drug Registration and Regulation in Uganda | NO | NO | NO | YES |
| Drug Registration and Regulation in Morocco | NO | NO | NO | YES |
| Other | - | - | - | - |
| Drug Registration and Regulation in Australia | NO | NO | NO | YES |
| Drug Registration and Regulation in New Zealand | NO | NO | NO | YES |