TypeOnline Course
Price$180 / Rs. 8500
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Admission Process

Admission Process

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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

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

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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 8Introduction of Export Documentation | Understanding of important terminologies
Lecture 9Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 10Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 11Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 12Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 13Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 14Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 15LC Discounting | How it works | How to calculate the LC discounting
Lecture 16Packing List | Importance | Things to include in packing list
Lecture 17Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 18Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 19Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 20Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 21Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 3Certification in Pharmaceutical Industry
Lecture 22GMP
Lecture 23Certification Pharmaceutical Companies / Plants
Lecture 24HACCP Certificate
Section 4Drug Dossier
Lecture 25Drug Dossier: Introduction to CTD
Lecture 26Asean Common Technical Document (ACTD)
Lecture 27ECTD
Section 5Training on Dossier Preparation focusing on drug registration in export countries
Lecture 28Basic Fundamentals of Export Dossier
Lecture 29Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 30Drug Master File
Lecture 31Site Master File
Lecture 32Practical Training on preparing DMF and SMF
Section 6Region Acronyms in Pharmaceutical Industry
Section 7Export Documentations : Pharmaceuticals
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 36Manufacturing license
Lecture 37GMP-certificate
Lecture 38Free Sale Certificate
Lecture 39CPP (Certificate of Pharmaceutical Product)?
Lecture 40Certificate of Analysis
Lecture 41Certificate of origin
Lecture 42Package Insert
Lecture 43Batch
Lecture 44Non-conviction Certificate
Section 10Pharma Export Process & Effective Documentation
Section 11Export Related Update / New Regulations
Lecture 46Impact of GST in Export
Lecture 47LUT (Letter of Undertaking) and It's Importance
Lecture 48Case Study - Export
Section 12Final Examination