3 December 2012 - 5 December 2012
To provide students with a comprehensive overview of the quality-related requirements and critical issues of the quality part of the dossier with interfaces to product development and post-approval maintenance. The various subjects, ranging from chemical synthesis of active substances and development of drug products to global quality trends, will be presented by international lecturers with extensive experience and expertise within chemical, pharmaceutical, and analytical development.
By the end of this module, the student should be able to:
the basic principles of how to design, develop, and document drug substances and drug products, i.e. to understand how data are generated, and how the work is regulated by guidelines and standards
- analyse and evaluate
development processes, reports, specifications, methods, and data - all seen from a regulatory point of view in order to ensure coherency and transparency of the quality dossier and other regulatory documentationDownload Flyer
CTD Module 3 and Quality Overall Summary Module 2, critical issues during development and in the submission stage, compiling the dossier with a view to future product maintenance.
• Development of Drug Substance and Drug Product in the Overall
• Development Programme
• Drug Substance (Synthesis-related Issues)
• Drug Substance (Solid State Characterisation)
• Drug Substance (Preformulation)
• The ICH Vision - Q8, Q9, Q10 and Q11
• CMC Documentation in relation to the Clinical Phases
• Drug Product
• Container Closure Systems
• Control of Drug Substance and Drug Product
• Developing Specifications: Drug Substance and Drug Product
• Stability, Drug Substance and Drug Product
• Certificate of the European Pharmacopoeia (CEP)
• The Quality Overall Summary
• Global Quality Dossier and Trends
Associate Principal Scientist, Nycomed Danmark, Denmark
Poul E. Bertelsen
Head of Section, Pharmaceutical Product Development, LEO Pharma A/S, Denmark
Karen Wibe Enevoldsen
BioPharmaLinx AB, Senior VP Quality and Regulatory Operations & NDA Regulatory Service AB, Biopharmaceuticals, Sweden
Ph.D. Chemistry, Director of Customer Project Management, PolyPeptide Laboratories AB, Malmö, Sweden
BSc, PhD, FRPharmS, CChem, FRSC, SENIOR TEACHING FELLOW AND VISITING PROFESSOR, Strathclyde Institute of Pharmaceutical and Biological Sciences, University of Strathclyde, Glasgow, Scotland
Alexander (Alastair) Davidson
Ph.D (Pharm) Executive Assistant, R&D Management, H. Lundbeck A/S Denmark
Michiel Ringkjøbing Elema
Project Manager, Novo Nordisk A/S, Denmark
Pharm. D., Co-ordinator Regulatory Science, The Medicines Evaluation Board (MEB), The Netherlands
Diana van Riet
Principal R&D Scientist, LEO Pharma A/S, Denmark
Brian Thoning Pedersen
Senior Pharmaceutical Scientiest, Takeda, Denmark
Erik Valentin Jørgensen
Department Manager, Novo Nordisk A/S, Denmark
Kirsten Nielsen Tallerup
Head of Department, NCE - New Products, LEO Pharma A/S, Denmark
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.
Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis.
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.
The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.
The participants are expected to study and be familiar with the mandatory references in advance of the module.