Pharmaceutical Export Documentation

Introduction

Features

Related Courses

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.

Few of the similar courses

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
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 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 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 20Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill

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]