Date to be announced
Contact us for more infoTRAINING TIMES
Impact of AI and digital technologies on project management and regulatory processes.
Identify the right risk management methods and recovery strategies for your projects.
Lifecycle management of project portfolios. Business case preparation and project evaluation techniques.
Learn about project planning techniques including reverse and long-term planning. Overlook cost control at both project and portfolio levels.
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.
Learn how to prepare the business case
Understand regulatory requirements for project management process documentation
Apply planning techniques for long-term pharmaceutical development processes
Navigate API and finished dosage form development processes
Recognize the role of a business analyst in the risk management process
Designed for professionals who want to enhance their expertise and advance their careers
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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HMH Management Consulting, CEO
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. Although born in Poland her international experience includes having worked in Spain, Argentina, Luxembourg, Scandinavian countries and Russia. Hanna worked in pharmaceutical production including R&D and API, creative sector – including activities performed “pro public bono”, as well as education and trainings development. Working as a professional in project portfolio management – her major achievement in the field was an introduction of portfolio management processes, organization and IT supporting tools set up in the Polpharma group, the largest pharmaceutical company in Poland (product portfolio adjustment to European Union standards and regulations, including R&D processes).
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Take a sneak peek at the trainer's presentation.
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