Aims and Objectives
This comprehensive course examines the fundamentals of early drug formulation, drug delivery systems, scale-up and manufacturing in a commercial setting. It also examines the interpretations and applications of regulatory guidelines. Most importantly, you will learn how these can be directly and pragmatically applied to the CMC dossier in the US, EU and Australian markets. By covering the basics of drug dosage and routes of administration to the finer points of drug delivery systems, legislation and regulations governing quality standards and product approval, the course provides practical guidelines on what studies need to be undertaken, for what specified reasons, and at that key stages of the drug development process.
This advances course is aimed at professionals working in the therapeutics industry, in biotech and medical companies, smaller start-up companies or larger companies with responsibility for drug formulation and development.
They may include:- Development Chemists and Technicians, Senior Drug Discovery Scientists, Quality Assurance Managers/Directors, Research Managers, Directors, Regulatory Affairs Managers/Directors, Pharmaceutical Development Manager / Scientist. Drug Development Professionals
Learn About:
- Role of formulation in product life cycle
- Prediction of potential problems for further drug formulation development, potential issues and problems in scale-up
- Best use of drug substance for pre-formulation studies to aid in candidate drug selection
- Overcoming solubility issues
- How to generate appropriate data to characterize the candidate drug and aid product design and development
- Identifying appropriate instrument techniques to gain useful information
- Various dosage forms and routes of administration
- Applying essential pharmaceutics to product dosage design
- The fundamentals of targeted delivery and drug delivery systems
- Applying the principles of validation
- Ensuring product stability and predictive methods
You will be enriched with a practical understanding of the issues associated with drug formulation, scale-up and manufacture of pharmaceutical and biotechnology drugs. Together with the practical tips and guidance, you will be able to apply the skills learned to:
- Select and design suitable dosage forms and drug delivery systems for your candidate drugs,
- Design and implement a development program including for stability
- Identify potential risks and issues for process development, optimisation, scale-up and validation.
Course Overview
We are only too familiar that a poorly or inappropriately formulated drug can lead to misleading failures at an early developmental stage. This could translate into loss of potentially useful molecules as well as lost opportunities and profits. In addition, within the product life cycle, there may be opportunities to reformulate existing drugs to new delivery systems thereby adding value, improving drug safety and/or efficacy, extending the product life and increasing revenue.
This comprehensive course examines the fundamentals of early drug formulation, solubility, drug delivery systems, scale-up and manufacturing in a commercial setting. It also examines the interpretations and applications of regulatory guidelines. Most importantly, you will learn how these can be directly and pragmatically applied to the CMC dossier in the US, EU and Australian markets. By covering the basics of drug dosage and routes of administration to the finer points of drug delivery systems, legislation and regulations governing quality standards and product approval, the course provides practical guidelines on what studies need to be undertaken, for what specified reasons, and at what key stages of the drug development process. This course covers a number of essential topics necessary for formulation and delivery systems development including:
- How to determine your key drivers for drug (re)formulation or new delivery systems
- Using bio pharmaceutics and design principles to tweak dosage form and drug delivery
- Critical elements of early pre-formulation/formulation studies
- Problem molecules – how to overcome poor solubility
- Drug delivery systems
- Key compliance issues from drug development for preparation of the CMC element eg drug and dosage stability issues
- Process design, development, optimisation and validation
This course is conducted in a vibrant and stimulating environment to enhance and enliven your learning experience. Principles and theories are accentuated with discussions and during the workshop participants will work on case studies, exercises and other activities.
Who Should Attend / Target Audience
This advanced course is aimed at professionals working in the therapeutics industry, in biotech and medical device companies, smaller start-up companies or larger companies with responsibility for drug formulation and development. They may include:
- Development Chemists and Technicians
- Senior Drug Discovery Scientists
- Quality Assurance Managers/Directors
- Research Managers/Directors
- Regulatory Affairs Managers/Directors
- Pharmaceutical Development Manager / Scientist
- Drug Development Professionals
Numbers will be limited due to workshops.
