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 |