TypeOnline Course
Price$90 / Rs. 5850
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Introduction

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Course Fees

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Syllabus

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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 Month 

90 USD (from payment outside India) / 5850 Indian Rupees for payment within India.

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 Live 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 countrie
  • 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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ADMISSION FROM INDIA – OFFLINE PROCESS

You can download the application form and attach demand draft or make online payment.

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INTERNATIONAL ADMISSION – OTHER THAN 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 3GMP - Basic Requirement for Export
Section 4Certification in Pharmaceutical Industry
Section 5Drug Dossier
Lecture 22Drug Dossier: Introduction to CTD
Lecture 23Asean Common Technical Document (ACTD)
Lecture 24ECTD
Section 6Training on Dossier Preparation focusing on drug registration in export countries
Lecture 25Basic Fundamentals of Export Dossier
Lecture 26Modules on Stability Study
Lecture 27Module on Interchangeability
Lecture 28Stability Testing of API
Lecture 29Stability Testing of Finished Pharmaceutical Products
Lecture 30Review Test on Stability Testing
Section 7Region Acronyms in Pharmaceutical Industry
Section 8Export Documentations
Section 9Comparison of Registration Requirement of Different Regulatory Bodies (GCC vs. US/EU/ASEAN/GCC/LATAM/CIS/Asia Pacific -except ASEAN)
Section 10Export Documentation Related Queries
Lecture 34Manufacturing license
Lecture 35GMP-certificate
Lecture 36Free Sale Certificate
Lecture 37CPP (Certificate of Pharmaceutical Product)?
Lecture 38Certificate of Analysis
Lecture 39Certificate of origin
Lecture 40Package Insert
Lecture 41Batch
Section 11Pharma Export Process & Effective Documentation