Online, part-time

Global Medicines Development MSc

The delivery of safe and effective medicines is central to this module. You will learn how the clinical development process is linked to a company’s strategy, ensuring medicines meet the needs of patients, healthcare professionals, policymakers, and regulators. Key topics include patient engagement, intellectual property, health technology assessment, and commercialisation. Through case studies and practical exercises, you will develop the skills to critically assess development strategies, craft patient-focused approaches, and design multidisciplinary plans that integrate compliance, market requirements, and patient access.

This module reviews the ethical principles and good practices underpinning the development and commercialisation of medicines, focusing on how the pharmaceutical industry should protect patients and the public. It explores key issues such as consent processes, regulatory frameworks, and pharmacoepidemiology. Through discussions and real-world cases, you will evaluate ethical dilemmas, explore robust patient involvement plans for multinational clinical programmes and assess risk-benefit evidence from clinical and non-clinical studies.

Suitable for both newcomers and experienced professionals, this module deepens your understanding of ethics, professionalism, and regulatory compliance in medicines development.

The foundational stages of drug development require a careful integration of theory and practice. You will explore the principles of chemistry, pharmacology, toxicology, and pharmaceutics, learning to design dosage forms and pharmaceutical processes tailored to clinical needs. Key topics include preclinical toxicology, pharmacokinetics, and regulatory requirements.

Through hands-on exercises, you will evaluate data supporting the progression of medicines into first-in-human trials, addressing challenges such as formulation, stability testing, and scale-up for clinical use. This module offers a comprehensive understanding of non-clinical development, vital for advancing innovative therapies.

Global regulatory frameworks guide the development, approval, and lifecycle management of medicines. You will study the interplay between science, public policy, and regulations, focusing on critical areas such as clinical trial authorisations, marketing authorisation, pharmacovigilance, and requirements for special populations.

Through interactive workshops, you will design regulatory strategies, prepare essential documentation, and tackle practical challenges, including risk minimisation and managing off-label medicines.

By the end of the module, you will have a comprehensive understanding of regulatory science and its role in ensuring medicines are safe, effective, and accessible.

Clinical trial design and management are pivotal to the successful development of new medicines. In this module, you will learn to develop clinical development plans, create robust trial protocols, and manage essential components such as investigator selection, vendor contracts, and data collection strategies.

Statistical methodologies, including power calculations and error analysis, are explored to ensure trial designs are scientifically sound and regulatory compliant.

Practical exercises and assessments will equip you with the skills needed to address real-world challenges, ensuring high-quality data generation and analysis throughout the trial process.

Ensuring drug safety throughout a medicine’s lifecycle is vital to protecting patients and maintaining public trust. This module examines the principles of pharmacovigilance and pharmacoepidemiology, covering risk assessment, adverse event monitoring, and safety management practices.

You will learn to create risk management plans, design systems for safety signal detection, and evaluate methodologies for generating reliable safety evidence.

Practical exercises will help you develop strategies to mitigate risks during clinical trials and post-marketing. By the end of the module, you will have a strong foundation in safety assessment and risk management essential for lifecycle management of medicines.

Managing clinical trials requires a balance of strategic oversight and practical expertise. This module equips you with the knowledge and tools to coordinate trials effectively, from single-site studies to large-scale, multinational projects.

Topics include site selection, patient recruitment, adverse event management, and ensuring quality across trial supplies. You will also learn to apply project tracking systems, manage data collection, and resolve challenges such as slow data flow or team dynamics.

By the end of this module, you will be prepared to lead complex clinical trial operations and maintain high standards of compliance and scientific integrity.

Medical Affairs professionals play a pivotal role in the development, commercialisation, and lifecycle management of medicines. You will learn how to execute the key functions of Medical Affairs practitioners, focusing on planning and leading initiatives such as medical education programmes and health technology assessments.

You will critically evaluate approaches to addressing drug development questions, considering factors like regulatory approval, stakeholder engagement, ethics, and corporate responsibility.

By the end of the module, you will have the skills and knowledge to lead strategic medical affairs projects that enhance the development and use of new medicines.

Advances in cell biology and regenerative medicine are revolutionising the development of innovative therapies. You will engage in an in-depth study of cutting-edge research and clinical applications in areas such as stem cell biology and cell-based therapeutics.

You will assess the safety and risks of advanced therapies, exploring their potential to address degenerative disorders and other unmet medical needs. You will learn to develop pharmaceutical plans for advanced therapies, equipping you with the skills to translate scientific discoveries into effective clinical solutions.

Bringing new medicines to market requires a deep understanding of the scientific, financial, and operational factors that drive commercial success. This module explores the key elements of business planning, market positioning, and investor relations, emphasising strategies that integrate manufacturing and market access considerations.

Through practical exercises and case studies, you will critically evaluate commercialisation strategies, create business plans, and assess factors influencing market penetration and profitability.

By the end of the module, you will be equipped with the skills to navigate the complexities of commercialising innovative therapies and achieving sustainable success.

This capstone project brings together all the knowledge and skills developed throughout the programme, challenging you to create a comprehensive development plan for a new pharmaceutical product.

You will evaluate strategic business decisions, navigate complex regulatory frameworks, and craft proposals that appeal to potential investors or collaborators. Practical application is emphasised, enabling you to integrate entrepreneurial insights into the development and commercialisation of innovative therapies.

This module prepares you to tackle real-world challenges in medicines development, equipping you with the expertise needed to lead and succeed in the pharmaceutical industry.