Clinical Development and Documentation

Summary

This four day course will provide you with an overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of CTD (Modules 2 and 5). The clinical sections are especially important when completing a marketing authorization of a new product or when labeling a product. The sections are also important in helping you meet the needs of patients and also when marketing the product.

The module is relevant for you if you are a regulatory employee who wishes to gain a better understanding of the interrelationships and complexities in clinical development and the current regulatory requirements for developing a new treatment. Our course also provides clinical development staff with the opportunity to gain a better understanding of the relationship between regulatory and clinical strategies as well as the documents that must be prepared prior to regulatory approval.  

Other course participants say:

"The course was well-structured with many really relevant topics and interesting presenters. This course really helps put together the bigger picture when working with clinical development."

Malene Olesen, Senior Regulatory Professional. 

"The course was very comprehensive and covered a multitude of aspects related to clinical development and documentation, both through the use of very knowledgeable presenters and workshops. All the course materials was highly relevant for individuals working with this topic."

Peter Gransgaard, Global Regulatory Affairs Manager, Ferring Pharmaceuticals A/S

"The scope of the course was extensive and gave me a broad understanding of clinical development with deep dives into different topics and development angles. The course leaders were great, fun, knowledgeable, and friendly. There was room for discussion and questions, and the atmosphere was excellent."

Annemette Geertsen, Lead Regulatory Professional, ALK-Abelló A/S

"Great content; well-organised and structured. Highly relevant information. I think this combination for Clinical Regulation plus the speakers' expertise with the FDA and EMA provide a strong basis for regulatory affairs professionals in their daily work with clinical drug development."

Carol Saldaña, Novo Nordisk A/S

"The course gives you a good overview of the regulatory aspects of clinical development and documentation, which is useful when working in Regulatory Affairs. The programme is well-organised with interesting topics and great presenters."

Dorthe Gyes, Associate Regulatory Professional, Novo Nordisk A/S

Keywords

• Global clinical development
• Global regulatory requirements
• Clinical study
• Early clinical development
• Clinical efficacy and safety trials
• Target product profile
• Biomarkers as clinical endpoints
• Pharmacokinetic, pharmacodynamics and special populations
• Clinical protocol
• Interactions and drug/drug interactions
• Statistics in clinical trials
• Pediatric development
• Clinical summaries and clinical overview
• Benefit-risk assessment tools
• Post-approval studies
• Pharmacovigilance
• Health Technology Assessment (HTA)
• Interactions with health authorities

Please note: 

As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.