Live Online Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For online attendees, you will receive joining instructions.

23 & 24 June 2026

2-Day Live Online Training

Register at the top of the page. The largest price saving of £400 will be applied.

Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Day 1

What Is a Project in Regulatory Affairs?

• Defining “project” and “project management” in the context of regulatory submissions and compliance
• Understanding why structured project management is critical in RA (e.g., meeting MAA/ANDA timelines, variation management, labelling updates)
• Using recognised methodologies (Waterfall, Agile, Hybrid) for regulatory projects
• Sharing experiences and lessons learned from real regulatory projects

Setting Regulatory Project Objectives

• Defining clear project goals, scope, deliverables, and compliance endpoints
• Aligning project objectives with strategic, quality, and business drivers
• Balancing cost, time, and regulatory constraints
• Establishing the “Right-First-Time” mindset for submissions

Regulatory Discussion:
Examples of global submission projects that failed or succeeded due to project-management factors.

Detailed Project Planning for Regulatory Projects

• Creating a Work Breakdown Structure (WBS) for submission or variation projects
• Allocating responsibilities using a Responsibility Assignment Matrix (RACI)
• Building realistic schedules and milestones (Gantt analysis) for regulatory deliverables (e.g., Module 3 completion, eCTD compilation, responses to questions)
• Developing communication, risk, and quality plans for regulatory teams

Implementing Risk Management in Regulatory Projects

• Identifying and evaluating regulatory risks: submission delays, data gaps, authority queries, resource bottlenecks
• Creating contingency plans and escalation routes

Exercise 1 – Planning a Regulatory Submission:
Participants develop a high-level project plan (timeline, key milestones, WBS) for a centralised MAA or variation submission and discuss approaches with the group.

Day 2

Executing and Controlling Regulatory Projects

• Tracking progress: dashboards, submission trackers, and change-control systems
• Monitoring quality and document version control
• Managing cross-functional communication between Regulatory, CMC, QA, and Clinical teams
• Handling delays, authority questions (DQRs), and late data inputs

Regulatory Project Monitoring & Reporting

• Establishing effective reporting systems for internal management and external partners
• Key performance indicators (KPIs) for RA project performance (on-time submission, number of queries, first-cycle approvals)

Case Study 1 – Managing a Centralised Procedure:
Walkthrough of a complex EU submission project — identifying bottlenecks, communication challenges, and how project control tools improved outcomes.

Leadership and Team Management in Regulatory Projects

• The role of the Regulatory Project Manager/Lead
• Building and motivating cross-functional teams (Regulatory, CMC, PV, Clinical, Marketing)
• Managing global affiliates and remote teams
• Effective communication with internal stakeholders and Health Authorities

Dealing with Challenges and Conflict

• Managing changing priorities, authority feedback, and internal constraints
• Techniques for negotiation, influencing, and stakeholder alignment

Project Closure and Continuous Improvement

• Conducting post-project reviews and lessons-learned sessions
• Capturing regulatory knowledge for future submissions
• Continuous improvement of project processes

Exercise 2 – Lessons Learned Workshop:
Participants review a regulatory project scenario, identify key enablers and constraints, and propose process improvements.

Dr Laura Brown is an independent pharmaceutical project management and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of managing projects in the pharmaceutical industry and has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including the leading title, Project Management for the Pharmaceutical Industry.