課程介紹

Are you interested in the pharma industry? Would you like to talk confidently about pharmaceuticals and healthcare?

The pharmaceutical industry is one of the most dynamic and exciting professions in the world. It can be hugely rewarding professiona

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哪些人適合這堂課？

• An ideal course for newcomers or anyone interested in the industry looking to enhance their pharma knowledge
• Those looking to talk confidently and become better prepared for working with the pharmaceutical industry
• Students, Professionals, Businesses, Patients, Carers and anyone looking to build their expertise in the pharma industry

學習目標

• Learn essential facts about medicines and the structure of the pharmaceutical industry around the world
• Answer questions about the industry today and the major developments
• Explain where are the major markets and who are the major players
• Explain which drugs are the most successful
• Explain which disease areas are of greatest interest
• Discover how the industry has evolved and how the industry is adapting

課程介紹

Hi! 

My name is Ron Wehrens and I’m a pharmacist from the Netherlands with 25 years of hands-on experience in pharmaceutical and medical supply management in developing countries.In case you are interested, you’ll find my CV available for download w

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哪些人適合這堂課？

• Anyone interested in improving access to medicines and health products in low and middle income countries

學習目標

• Understand the pharmaceutical industry
• Pharmaceutical and healthcare needs in low and middle income countries
• Detailled insight in all steps of the supply cycle (e.g. Specification, Quantification, Procurement, Storage, Use)
• How to forecast/quantify medicines and health products
• Procurement
• Warehousing and distribution logistics
• Rational use of medicines

課程介紹

The compliance with GMP (Good Manufacturing Practices) standards is the decisive aspect for the production of high quality products. They are mandatory for all Pharmaceutical laboratories, thus health authorities performs inspection and audits in ord

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哪些人適合這堂課？

• Current Pharmaceutical industry employees
• People interested in entering the world of the pharmaceutical industry, regardless of the future position

學習目標

• You will learn the most important pharmaceutical regulation and its importance, obtaining a basic overview of the GMP requirements in pharmaceutical industry
• You will become familiar with the technical terms of the GMP field and their meaning.
• You will learn the fundamental parts of the pharmaceutical industry.

課程介紹

Are you curious about the drug R&D process?  Are you considering a career in the pharmaceutical industry? 

The discovery and development of medicines is one of the most interesting and impactful areas of human endeavor.  And the pharmaceutical indus

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哪些人適合這堂課？

• Anyone interested in knowing how drugs are discovered,developed, and marketed in the US.

學習目標

• Students will learn how modern drugs are discovered, developed and marketed by “Big Pharma” in accordance with FDA regulations.

課程介紹

If you are looking for Pharma Regulatory affairs course to start career as Regulatory Professional without paying huge amount or money then you are on right platform.

This course is for starting career in Regulatory affairs with certificate of compl

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哪些人適合這堂課？

• Pharmaceutical industry employees
• Pharmacy Students & Pharma Professionals
• Chemistry students
• Science Graduates
• Diploma in pharmacy
• Pharma professionals

學習目標

• Basic concepts Pharma Regulatory Affairs
• Advanced Regulatory Affairs
• How Regulatory Authorities Regulates Drug product
• Career in Regulatory Affairs
• Job opportunities
• eCTD & CTD Structure
• Dossier Preparation & Submission
• Drug master file
• Submission of Drug Master File
• eCTD Modules
• General Demonstration of eCTD Software
• General demonstration of eValidator

課程介紹

Introducing a Pharma Course for Pharma/B.Sc students, graduates, industry professionals.

This course will help you with basic concepts related to the functioning of the Pharma Industry. The focus is on Indian market but we have given global touch so

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哪些人適合這堂課？

• Anyone who is looking to get entry in Pharmaceutical Industry
• Existing Pharma Professionals who are looking to progress in their jobs

學習目標

• Indian Pharmaceutical Industry – Basics and other relevant concepts
• By the End of this course, you will have full understanding of Basic Pharma Concepts including types of drugs, company business models, relevant companies and their drugs and much more.
• This course covers relevant topics which will help you in passing your job interviews.

課程介紹

This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and ex

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哪些人適合這堂課？

• Pharmacy students, consultants who are doing computerised system validation, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers

學習目標

• Pharmacy,
• This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This two-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. The course will provide principles and an overview of the overall computer systems compliance.

課程介紹

Want insights into the biggest revenue-changing events?

By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.

Branded drug companies can experi

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哪些人適合這堂課？

• Generic pharmaceutical company portfolio managers
• Branded drug lifecycle management, sourcing, procurement, and supply chain professionals
• Pharmaceutical drug analysts, investment analysts, and patent analysts
• Patent analysts
• Patent Landscape Profilers
• Biotech and Pharma Investors
• Supply chain, sourcing, purchasing managers, procurement, wholesalers, distributors, and warehouses
• Good Manufacturing Practice (GMP) facility owners and operators
• Pharmaceutical regulatory affairs professionals, lawyers, consultants, and founders
• Drug and medical device development managers

學習目標

• Finding and evaluating generic drug market entry opportunities
• Branded drug lifecycle management
• Find generic drug entry opportunities
• Track drugs in development and explore new indications for existing drugs
• Study failed patent challenges to develop a better strategy
• Collect competitive intelligence by examining contractual disputes
• Track litigation to anticipate early generic entry
• Find and evaluate business opportunities
• Assess levels of generic competition
• Use drug price ranges to evaluate price elasticity
• Determine optimal prices before launch
• Evaluate buyer power with data on reimbursement segmentation
• Align distribution methods with information on where and how drugs are purchased
• Evaluate branded and generic market opportunities globally
• Anticipate 505(b)(2) and biosimilar approvals
• Strengthen new formulation patents by studying prior claims and litigation
• Adapt your gmp facility to capture changes in demand with brand erosion and generic launches as drug patents expire
• Position regulatory affairs to capture emerging opportunities
• Understand the roles of patents, trade secrets, trademark, and other forms of intellectual property protection in protecting branded pharmaceutical and biotechnology drugs
• Proactively adapt sourcing, purchasing, and supply chain management to anticipate changes in supply and demand with generic drug entry

課程介紹

Audits is one of the best tools to learn and understand the process and the quality system of any company. For this reason, internal audits to your company and audits to the pharmaceutical raw material suppliers are usually performed to ensure the qu

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哪些人適合這堂課？

• Current pharmaceutical industry employees
• Employees from companies supplying products to pharmaceutical companies
• People interested in entering the world of the pharmaceutical industry which would like to have a deeper knowledge

學習目標

• General information on audits
• Which types of suppliers should be audited
• The audit process, how to plan and conduct audits efficiently
• Auditor behaviors and techniques, to face the various challenges
• How to audit API manufacturers
• Other interesting related topics

課程介紹

Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integri

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哪些人適合這堂課？

• Pharmacy students, Pharmaceutical professionals, consultants. This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Quality heads • Software vendors and suppliers

學習目標

• This course has been updated to include brief understanding about data integrity requirements for pharmaceuticals with guideline requirements about data integrity, audit trail review, data integrity in production, data integrity in analytical laboratories and data integrity in microbiological laboratories