SUMMARY
On this two-day course, you get an overview of and insight into the considerations and decisions that lie behind the successful development of new medicines.
The course is taught by an extensive team of experienced experts, who, among other topics, teaches you how to select the right molecules and what the purpose and content of the clinical development phases (I-III) are.
You also learn how a clinical development plan is developed, including the regulatory requirements that must be met, such as the benefit-risk balance within a specific disease area.
A key parameter for success is collaboration with other stakeholders, and on the course, you also learn how to establish good collaboration between Clinical Development and Clinical Operation – and how to communicate with authorities, e.g. about clinical data and its value.
After the course, you will also know about the increasingly central role that Real World Evidence plays, as well as how clinical development will take place in the future.
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Keywords
- Clinical development plans
- Clinical development phases (I-III)
- Study design and use of clinical data
- Statistic and data management
- Pharmacovigilance
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Course leader & lecturers
- Kirsten HartingCourse leaderMedical Doctor and Executive MBA
Pharma-Business - Claudia Pierleoni-NielsenLecturerHead of Safety Surveillance, Global Safety
Leo Pharma A/S - Helen ShennanLecturerRegulatory Affairs Director
AstraZeneca A/S - Tine Bryan StensbølLecturerSenior Vice President
H. Lundbeck A/S - Sofie de Fine LichtLecturerMedical Evidence Team Lead, Epidemiology and Real-World Evidence
AstraZeneca A/S - Niclas PetriLecturerPrincipal Clinical Pharmacology Scientist
Novo Nordisk A/S - Anna Karina Trap HuusomLecturerSenior Director, Biostatistics & Programming, H. Lundbeck A/S
H. Lundbeck A/S - Peter BergqvistLecturerMedical Writer, Owner
Öresund Medical Writing AB
Is this course for you?
The course is for you if you’re involved with clinical trials in any capacity, e.g. clinical development, clinical operations, statistics, medical writing, safety, investigators, or in a CRO or biotech.
It is also relevant if you’re indirectly involved in conducting clinical trials (e.g. being employed in a health authority agency) and need a general understanding of clinical development.
What you will learn
- Basic principles of clinical development.
- Study design and the different phases (I-III) of clinical development.
- Basic statistical principles and data management.
- Regulatory requirements in clinical development.
- Communication of clinical data and successful launch of new medicine.
What your company will get
- An employe who understand the basic principles of clinical development.
- An employee with solid knowledge about Clinical Trials I-III.
- An employe who understand the importance of collecting and analysing clinical data.
- An employee who has insights into regulatory requirements, including benefit-risk balance.
- An employe who knows how to communicate the data and value of clinical data to HCPs and other stakeholders.
Course calendar
Day 1
- Developing a new medicine: considerations when selecting the molecule for development
- Target Product Profile and Business case
- Overview of the Clinical Development process: the Clinical Development Plan
- Early Clinic Development (phase I) and specific considerations
- Phase II & phase III
- Safety in drug development
- Statistics and Data Management
- Working with the authorities – Regulatory Affairs
- Clinical Operation: Trial Management and CRA role
Day 2
- Decentralised clinical trials.
- Real World Evidence
- Medical Writing as part of the Regulatory File and presentation of clinical data
- Value-creating communication of clinical data to healthcare professionals and other stakeholders, including compliance rules
- Successful launch of the new medicine to the right price via multichannel initiatives
- Future aspects
Registration
Registration deadline25 Oct 2023
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
Prerequisites
There are no prerequisites for this course, but we recommend that you have a Bachelor’s degree or similar as a minimum.
Examination
There is no examination for this course.
Course leader
Pharma-Business
Lecturers
Leo Pharma A/S
AstraZeneca A/S
H. Lundbeck A/S
AstraZeneca A/S
Novo Nordisk A/S
H. Lundbeck A/S
Öresund Medical Writing AB
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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