Clinical Development and Applied Good Clinical Practice (GCP) Course

Clinical Development and Applied Good Clinical Practice (GCP) Course

Good Clinical Practice, or GCP, is the foundation of the quality system when conducting clinical trials. While GCP courses have traditionally been taught with a top-down, slide-deck lecture approach – this course is different. Instead of drowning you in one-way communication concerning GCP theory, we focus on ensuring you gain a clear understanding of how the theory is used in practice and what is key when planning and conducting a clinical trial.

Aside from some initial basic knowledge sharing in lecture style, you’ll work together with your instructors, Trine Stougaard and Birgitte Sloth, and with the other participants to build a theoretical clinical trial from the ground up. Through interactive discussions and activities, you’ll gain knowledge on how to design and conduct a clinical trial per GCP assuring the rights, safety and well-being of trial participants as well as high data integrity that will guarantee that the trial is compliant with ethical and regulatory requirements. 

You will benefit from our instructors' decades of industry experience in clinical trial management and use of GCP. 

In addition, you will receive a 1-year free membership to the Pharma IT Network – a private, online community where you can ask questions and follow up on course concepts long after your training date.

About Instructors

Birgitte Sloth holds 20+ years of experience in the pharma industry and academia, working with Clinical Science and Global Trial Management (Phase I-III) both as Clinical Scientist, Global Trial Manager, Clinical Project Manager, and People Lead. As Pharma IT’s VP of Clinical Operations, she leads our team of expert Clinical Science & Trial Operations and Medical Writing Consultants. Birgitte has experience with planning, conduct and finalization of different trials with focus on early phase projects, and proof of concept trials in multiple different indications, and she is also experience with rare disease programs. 
She holds both a PhD and Postgraduate Diploma Degree in Pharmaceutical Medicine with a focus in Clinical Pharmacology. 

Trine Stougaard holds 18+ years of experience with the operational aspects of planning and conducting global clinical phase II-IV trials and non-interventional studies (from idea to publications incl. planning and conduct of Global Expert Panels). Extensive experience with outsourced clinical trials (from contracting to publications), CRO collaboration including CRO oversight, project management and stakeholder management.

Maria Iversen holds 15+ years of experience within the clinical operational aspects of planning, conduct and reporting of global clinical phase I-IV trials, with a focus on late-stage trials. Maria has extensive experience in CRO/vendor collaboration including sponsor oversight, project management and vendor management as well as process development. She holds a Master in pharmaceutical science and has worked in biotech companies, medium size and big pharmaceutical companies within oncology, diabetes, allergy, growth disease and gastrointestinal disorders.

Participants will leave this course having:

• Understood GCP principles and how to apply them in the planning and conduct of clinical trials
• Learned about the different phases of a clinical research program and common study designs and terminology
• Gained knowledge of the different stakeholders, CROs and vendors collaborating in a clinical trial

Who should participate? Anyone who will be involved in the planning and conduct of a clinical trial looking to gain the basic understanding of clinical research and GCP requirements. No prior knowledge is required.

Logistics: The course is held in person and the duration is one day, from 9 AM to 4 PM. The course will be held in person at Pharma IT's office in Copenhagen (Skelbækgade 2, 1717 København).

Your purchase includes:

• Meeting materials
• Breakfast, lunch & afternoon snack
• Certificate of course completion
• 1-year free membership to the Pharma IT Network