InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 22500 INR.
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pharma export documentation training



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Course Content

This online course provides an understanding of export documentation requirements for export of pharmaceutical.

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 focuses on pharmaceutical exports. Hence, this course provides real life examples and insights of documentation which helps candidates to understand specific pharmaceutical export requirements.

In this online self-paced module, participants will be understanding about the food regulation and commercialization process in detail. Therefore, it is easy and convenient to access 24×7.

The course trains the candidate on skill set required pre-registration, registration and post registration process effectively.  Moreover, Course covers fundamental to advance learning on drug registration process, regulation, and strategic management process for effective decision making. Above all, this course features pharmaceutical export business documentation process.

  • Title: Advance Certification in Pharmaceutical Export Documentation
  • Course Code: RYD-043
  • Duration: 1 Month
  • Nature of course: Online distance learning course. So, course can be accessed online across anywhere 24×7
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course

Who should attend this course? 

  • Those who are handling Pharmaceutical international business or export process.
  • Professionals who involve in pharmaceutical international marketing operation.
  • Import – export professional who requires detailed understanding of the pharmaceutical export business management.
  • Fresher or beginners, those who want to make a career in Export Department.
  • MBAs who want to have the rewarding career in pharmaceutical international marketing.

Course Features

  • The course covers various export documentation requirements.
  • Simulation to real life decision making in international business department. Therefore, it helps to enhance the strategic decision making.
  • Advance training on pharmaceutical registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the pharmaceutical export documentation process.

Course Content

  • Introduction to International Trade
  • Detailed 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
  • 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
  • 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 information regarding the component of pharmaceutical dossier.
Section 1Pharma R&D | Understanding Discovery to Commercialization Process
Lecture 1Introduction to Pharmaceutical Export
Lecture 2Export | Type of Export | Marchant Exporter
Lecture 3R&D Process & Introduction to drug discovery
Lecture 4Investigational New Drug Application (INDA)
Lecture 5New Drug Application (NDA) 
Lecture 6Basic concept and understanding of the Generic Drug 
Section 2Key Export Documentations | Detailed Study
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
Lecture 22Non-Conviction Certificate
Lecture 23Review Test on Export Documentation
Lecture 24Transshipment
Lecture 25GMP | cGMP | WHO GMP 
Lecture 26Pharma Export Process & Effective Documentation - Step By Step
Section 3Plant Certifications and Requirements for Export
Lecture 27Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 28Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 29WHO-GMP Certification Scheme 
Lecture 30Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 31ISO Certification and ISO Audits
Lecture 32HACCP Certificate | Implementing HACCP system in Pharmaceutical Company 
Section 4Drug Dossier | Specific Pharma Requirements
Lecture 33Introduction to Common Technical Document (CTD)
Lecture 34Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 35Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 36Chemistry, Manufacturing & Controls 
Lecture 37Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 38Practical Understanding on Drug Master File Preparation and Submission
Lecture 39Site Master File
Lecture 40Package Insert
Section 5Advanced Strategic Management - For Export Business
Lecture 41Licensing - Advance Learning 
Lecture 42Step By Step Implementation of Licensing Deal
Lecture 43Pharma Export - Requirement Specific to country [Case Analysis]