Regulatory Affairs is one of the most in-demand professions in the pharmaceutical and biopharmaceutical industry. The healthcare products landscape has evolved substantially in the past few decades. Today there are new emerging technologies, an improved understanding of patients' and consumers' needs, and a truly global marketplace. Regulatory professionals who can successfully navigate this new landscape are in high demand and short supply. The aim of this online module is to introduce participants to the fundamentals of Regulatory Affairs, providing them with basic knowledge of the regulations as they apply to (bio) pharmaceuticals. This module will cover international regulatory requirements with emphasis on European Union, the US, Japan, Australia, Canada and other global territories with market implications. Regulatory requirements for each system will be presented including classification, marketing submissions and post-approval requirements. Developing regulatory strategies for global market introduction and organising for the challenges of global regulation will be considered. Developing EU filing procedures and strategies will be covered in conjunction with practical issues with FDA applications including prior approval supplements (PAS).

Introduction to pharmaceutical regulatory affairs and (bio) pharmaceutical legislation. Quality systems for regulated industries. EU and US legislation and regulatory bodies' overview. Role of RA professional. Regulatory responsibilities. Legal basis for regulation. Regulatory affairs department roles and responsibilities. Overview of cGMP requirements in the regulations. Development and manufacturing initiatives (ICH Q8, Q9, Q10, Q11, QbD, PAT, design space, continuous manufacturing). Drug development and the marketing authorisation process. Selected topics on quality systems. Regulatory processes for clinical trial applications and marketing authorisation (MA) process. Overview of pharmacovigilance responsibilities and risk management throughout drug development and lifecycle.

On completion of this module students will be able to: 1. Describe the legal basis for the regulation of (bio) pharmaceutical products. 2. Understand the main phases of the drug development process and the regulatory requirements that apply. 3. Demonstrate a knowledge of the structure of the regulatory systems and filling procedures regionally and globally. 4. State and explain the similarities and differences between EU, US and global regulatory market requirements with particular attention to the current directives and regulations. 5. Describe the legal framework for interactions between intellectual property and lifecycle considerations for (bio) pharmaceutical products. 6. Demonstrate the role and activities of a regulatory affairs function in an organisation with respect to the requirements of regulatory and certification bodies.

On completion of this module students will be able to: Acknowledge the professional and ethical responsibility for regulation for the biopharmaceutical industry.

N/A

The module is taught via online lectures through an online learning platform. Guest speakers at the cutting edge of current industry regulatory affairs will also present during the programme. These lectures will be supplemented with additional reading material, assignments, discussion forums and on-line quizzes via Moodle.