An Introduction to the Pharmaceutical Industry: A Beginner’s Guide

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Course Overview

 

Developing a drug is a complex, timely and expensive process. It takes many years to develop a drug before it is put on the market. During this period, data is gathered to demonstrate the drug is safe and effective.

 

During this short online course, you will gain a complete overview of the drug development and manufacturing process. Focused on small molecules (traditional pharmaceuticals) you will examine how they are tested during pre-clinical and clinical stages to ensure safety and effectiveness. You will learn about manufacturing techniques and procedures. You will also touch on the regulatory requirements that dominate drug development.

 

Once completed, you will have a solid understanding of the industry and be well placed to communicate with technical professionals.

Learn more about how we deliver live online training.

 

What is included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Key Learning Objectives

  • Develop confidence and credibility when talking with your colleagues/clients
  • Briefly discuss other therapeutic products such as biopharmaceuticals, vaccines and cell & gene therapies
  • Understand the various stages of developing a pharmaceutical product from drug discovery through to clinical trials
  • Examine how a drug is made and the importance of quality control
  • Understand the science and technical terminology of the various stages so you have the confidence in your role
  • Learn about the various regulatory procedures and why they are important
  • Grasp key pharmaceutical trends and the future direction on the industry such as artificial intelligence and big data

 

Course Outline

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Module 1

Overview of the pharmaceutical industry

  • History of the pharmaceutical industry
  • Industry drivers and trends
  • Introduction to different therapeutic products
    • Traditional pharmaceuticals (small molecules)
    • Biopharmaceuticals
    • Vaccines
  • Overview of the drug development stages
    • Pre-clinical through to approval
  • Understand the science of therapeutic treatments
    • How do they treat a disease?
Module 2

Drug development: Discovery through to clinical trials

  • Understand how new drugs are discovered
  • Developing the drug ready for clinical trials (pre-clinical)
    • Gathering early safety data such as toxicology
    • Formulation / quality
    • Understand the major challenges during pre-clinical
  • Clinical trials
    • What is the aim of a trial?
    • Understand the clinical trial process and stages in clinical development
    • Understand the major challenges during clinical trials
Module 3

Manufacturing a pharmaceutical product

  • Examine the pharmaceutical manufacturing process
  • What is Good Manufacturing Practice (GMP)?
  • Understand the various processes in place to ensure quality and patient safety
  • Examine the major challenges of manufacturing
Module 4

Regulatory affairs and quality

  • Why is the pharmaceutical industry so regulated?
  • Who regulates pharmaceuticals: Competent authorities
  • What regulations exist throughout the development of a drug: GLP, GMP etc.
  • Marketing authorisations – getting approval for your drug
  • Examine the role of post market surveillance (pharmacovigilance)
Module 5

Future trends of the industry

  • Industry 4.0 and AI
  • Advanced therapies (cell and gene therapies)
  • Peptides and oligonucleotides

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff in technical writing.

 

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry.

This course is specifically designed for professionals who are not technical experts but wish to understand how pharmaceuticals are developed and manufactured. It will provide you with comprehensive overview of the sector to support you in your job.

Sectors and job roles this course is most suited for include:

  • Technical professionals starting out in the pharmaceutical industry who require a comprehensive overview
  • All supporting functions such as marketing, finance and IT
  • Investment Professionals
  • Recruitment Professionals
  • Legal and IP Professionals
e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.

 

 

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training