Pharma & Biotech

Mastering Projects and Regulatory Milestones in Generic Drug Development

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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 INCLUDE

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

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

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?

Designed for professionals who want to enhance their expertise and advance their careers

Senior Management

Strategic Planners

Business Development

Portfolio Planners

Project Managers

Regulatory Affairs

KEY TOPICS

Best practices in project portfolio management

Project management methodology

Planning in the generics industry

TRAINERS

Alice D’Alton

European Regulatory Affairs Limited, Managing Director

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. Experienced in managing EU compliant dossiers (Modules 1 – 5) including compliance, DCP/MRP variation applications, Regulatory Strategy for the EU and Accession Territories, including in-licensing, Quality Overall Summaries for human and veterinary medicinal product applications and Type II variations, Paediatric Investigation Plans (PIPs) for new fixed combination applications and Paediatric Use Marketing Authorisations (PUMAs), Clinical Trial Applications, including the Voluntary Harmonisation Procedure (VHP), Orphan designation applications, Scientific advice and pre-submission meetings with the EMA and national Competent Authorities, Running and support of Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure, and national applications, eCTD software and lifecycle management, Quality Management System and SOPs incorporating regulatory affairs, pharmacovigilance, quality and admin functions, Team and Human Resource Management of varying levels of experience and job descriptions and responsibilities Qualifications include a degree in Environmental and chemical science as well as a certificate in counselling. Pre-pharma experience includes working as an Environmental Laboratory technician, Quality Control Analyst and Scientific Information Specialist (processing and reviewing published literature for inclusion in a searchable database tool).

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