Mastering Projects and Regulatory Milestones in Generic Drug Development

On request or In-house only

1850 €

WHY SHOULD YOU ATTEND?

Apply agile principles within a regulated environment

Impact of AI and digital technologies on project management and regulatory processes.

Develop processes for APIs and finished dosage forms

Identify the right risk management methods and recovery strategies for your projects.

Integrate the regulatory strategy into project success criteria

Lifecycle management of project portfolios. Business case preparation and project evaluation techniques.

Strategic alignment and planning in the generic industry

Learn about project planning techniques including reverse and long-term planning. Overlook cost control at both project and portfolio levels.

OUR ONLINE TRAINING EXPERIENCE INCLUDES

Live, Interactive Format

Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

Full Access via Client Zone

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Certificate of Completion

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

LEARNING OBJECTIVES

Differentiate between targets and strategy

Learn how to prepare the business case

Align projects and portfolios to strategic business objectives

Understand regulatory requirements for project management process documentation

Clarify the relationship between goals, targets, and objectives within strategy

Apply planning techniques for long-term pharmaceutical development processes

Manage cost control on both project and portfolio levels

Navigate API and finished dosage form development processes

Use methods for estimating project management risk

Recognize the role of a business analyst in the risk management process

WHO IS THIS TRAINING FOR?

Senior Management

Strategic Planners

Business Development

Portfolio Planners

Project Managers

Regulatory Affairs

Continuous Improvement Staff

Organizational Development

KEY TOPICS

Best practices in project portfolio management

Project management methodology

Planning in the generics industry

Strategy in the generic pharma industry

Risk management and recovery of troubled projects

How to become more agile?

TRAINER

Alice D’Alton

Started in Pharma Regulatory Affairs over 14 years ago, initially in a manufacturing facility in Ireland. Joined Ivowen regulatory affairs consultancy over nine years ago and became Regulatory Affairs and Business Manager after four years. Became Managing Director and owner of the consultancy in 2021.

Hanna Hanć

Qualified and experienced in business management, consulting and project management (MBA,PMP). Hanna is a business management consultant, having a considerable experience in companies undergoing restructuring, particularly as a result of privatization.

TESTIMONIALS

A great overview of state of the art PM in generic business. The discussions on topics from real experience were especially interesting given his broad area of expertise (technical aspects of development, IP, sourcing, RA, portfolio) because it's all related!

Project Manager, Zentiva

It was a good overview on Project Management tools and skills. A good starting point for PM implementation.

Project Manager Pharmaceutical Development, Tecnimede

Keep up the excellent standard of training courses!

FDF Industrialisation Manager, Medichem Manufacturing

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