TypeOnline Course
Student Enrolled5
Price$180 / Rs. 8500
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Introduction

Duration

Course Features

Eligibility

Syllabus

Admission Process

This is a real-life learning course which is specially prepared and designed not only for the beginners but also for those who are currently engaged in the activities of import & export but are not too conversant with their export documentation and procedures. This course is conducted online-distance mode. This course is specifically focused on pharmaceutical exports. Real Life Examples and insights of documentation helps candidates to understand specific requirement for exporting the pharmaceuticals.  

1 Week

1. Orientation to job related practical aspects of the pharmaceutical export is covered in this course

2. Simulation to real life working in International Marketing Department.

3. Access to real life export documentations etc.

4. Access to Pharmaceutical Case Studies

5. Attend Lectures of all different chapters / study content.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

  • Introduction to International Trade
    Deatiled Understanding of Pharmaceutical Export – Why and How !
  • Scanning of international environment: Social, political, legal, economic, cultural environment for overseas markets;
    Factors affecting international trade: Methods of entry
  • WTO/GATT
  • All documentations required for export – A Preview !
  • Pre-requirement for Pharmaceutical Export
  • Common export documentation: Commercial Invoice, Export Packing Slip, Proforma Invoice
  • Transportation Documentation: Airway Bill, Bill of Lading
  • Export Compliance Documents: Export Licenses, Destination Control Statement
  • Certificate of Origin
  • Other Certificates: Certificate of Analysis, Certificate of Free Sale, Ingredients Certificate, Inspection Certificate, Pre-Shipment Inspections,
  • Letter of Credit – Importance and documents required to open LC
  • Basic Understanding in regulatory requirements of Innovative and Generic Products
  • Documentation in Pharma – WHO GMP, ISO CERTIFICATION, DOSSIER, FREE SALES CERTIFICATE etc.
  • Basic Training in Dossier – CTD, ACTD, ECTD formats
  • Country Specific export requirements – ASEAN countries
  • Country Specific export requirements – GCC countries
  • Medical Device Exports – GMP, CE marking requirements

Registration requirements of Pharmaceuticals in various regulatory agencies.
Pharma Dossier – Importance. Short training on dossier preparation to get first hand informations regarding the component of pharmaceutical dossier.

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ADMISSION FROM INDIA

Online Admission Process

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Section 1Fundamental Sessions
Lecture 1Introduction to Pharmaceutical Export
Lecture 2Drug discovery to Commercialization Process
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA)
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Patents Vs. exclusivity - take a closer look !!!
Section 2Key Understanding of Pharmaceutical Export & Export Documentations
Lecture 7Pharma Export What? When? and How?
Lecture 8Types of Export Documentation
Lecture 9Benefit of Export Documentation
Lecture 10Function of Export Documentation
Lecture 11General Export Documents and Terminologies
Lecture 12Proforma Invoice
Lecture 13Commercial Invoice
Lecture 14Custom House Agents
Lecture 15Packing List
Lecture 16Certificate of Origin
Lecture 17Transport Documents
Lecture 18Documents Required for Payments
Lecture 19Review Test on Export Documentation
Section 3Certification in Pharmaceutical Industry
Lecture 20GMP
Lecture 21Certification Pharmaceutical Companies / Plants
Lecture 22HACCP Certificate
Section 4Drug Dossier
Lecture 23Drug Dossier: Introduction to CTD
Lecture 24Asean Common Technical Document (ACTD)
Lecture 25ECTD
Section 5Training on Dossier Preparation focusing on drug registration in export countries
Lecture 26Basic Fundamentals of Export Dossier
Lecture 27Modules on Stability Study
Lecture 28Module on Interchangeability
Lecture 29Stability Testing of API
Lecture 30Stability Testing of Finished Pharmaceutical Products
Lecture 31Review Test on Stability Testing
Lecture 32Drug Master File
Lecture 33Site Master File
Lecture 34Practical Training on preparing DMF and SMF
Section 6Region Acronyms in Pharmaceutical Industry
Section 7Export Documentations
Section 8Comparison of Registration Requirement of Different Regulatory Bodies (GCC vs. US/EU/ASEAN/GCC/LATAM/CIS/Asia Pacific -except ASEAN)
Section 9Export Documentation Related Queries
Lecture 38Manufacturing license
Lecture 39GMP-certificate
Lecture 40Free Sale Certificate
Lecture 41CPP (Certificate of Pharmaceutical Product)?
Lecture 42Certificate of Analysis
Lecture 43Certificate of origin
Lecture 44Package Insert
Lecture 45Batch
Section 10Pharma Export Process & Effective Documentation
Section 11Export Related Update / New Regulations
Lecture 47Impact of GST in Export
Lecture 48LUT (Letter of Undertaking) and It's Importance
Section 12Case Study: Export Country Anslysis