2024-02-28 2024-02-28 , online online, 1,890 € zzgl. MwSt. Dr. Volker Blust https://www.forum-institut.de/seminar/24042470-preclinical-development-from-bench-to-first-in-human/referenten/24/24_04/24042470-online-seminar-pharma-preclinical-drug-development_blust-volker.jpg Preclinical development: From bench to first in human

Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.

Topics
  • Regulatory framework for the preclinical stage
  • Drug discovery and formulation development
  • Pharmacology, pharmacokinetics and toxicology: The basics
  • Essential preclinical studies
  • Documentation and Scientific Advice
  • Special case: Biologics and biosimilars


Who should attend
The seminar is aimed at specialists and managers in the pharmaceutical industry who

  • are looking for a compact introduction to preclinical research.

  • need a basic preclinical understanding for their daily work in the field of small molecules (day I+II) and/or biologics (day III)

In particular, staff from R&D, clinical research, preclinical, toxicology, analytical, regulatory and medical scientific departments will benefit from this seminar.
Aims and objectives
After Day I+II, you will be familiar with the regulatory framework for preclinical - focus on small molecules. You have intensively dealt with the sub-areas of (safety) pharmacology, pharmacokinetics and toxicology and you know which challenges exist in formulation development.

You have deepened the required preclinical study program to generate data for clinical phase I as well as the requirements for preclinical documentation. Last but not least, you will be able to assess when Scientific Advice on non-clinical issues is appropriate.

After Day III (optionally bookable), you will be familiar with the preclinical specifics regarding biochemicals and monoclonals too.
Your benefit

As part of this compact course, our experts will teach you how to move quickly and efficiently from drug screening to first-in-human studies.

Here you will receive first-hand regulatory and practical expertise.

On day I+II our experts will share their know-how in the field of small molecules with you, on day III the focus will be on biochemicals and monoclonals.

Online seminar Pharma - Preclinical drug development

Preclinical development:
From bench to first in human

- Online training -

Benefits
  • Different point of views
  • The most important in 2.5 days
  • Practical knowledge for direct implementation
  • Case studies/practical activities
  • Officially certified according to ISO 9001 + ISO 21001

Webcode 24042470

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

22-24/04/2024

22-24/04/2024

Zeitraum

Day I: 09:00 am - 5:30 pm - seminar
Day II: 09:00 am - 5:15 pm - seminar
Day III: 09:00 am - 12:45 pm - seminar
You may dial in 30 minutes before the training starts.

Day I: 09:00 am - 5:30 pm - seminar
Day II: 09:00 am - 5:15 pm - seminar
Day III: 09:00 am - 12:45 pm - seminar
You may dial in 30 minutes before the training starts.
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.

Topics

  • Regulatory framework for the preclinical stage
  • Drug discovery and formulation development
  • Pharmacology, pharmacokinetics and toxicology: The basics
  • Essential preclinical studies
  • Documentation and Scientific Advice
  • Special case: Biologics and biosimilars


Who should attend
The seminar is aimed at specialists and managers in the pharmaceutical industry who

  • are looking for a compact introduction to preclinical research.

  • need a basic preclinical understanding for their daily work in the field of small molecules (day I+II) and/or biologics (day III)

In particular, staff from R&D, clinical research, preclinical, toxicology, analytical, regulatory and medical scientific departments will benefit from this seminar.

Aims and objectives

After Day I+II, you will be familiar with the regulatory framework for preclinical - focus on small molecules. You have intensively dealt with the sub-areas of (safety) pharmacology, pharmacokinetics and toxicology and you know which challenges exist in formulation development.

You have deepened the required preclinical study program to generate data for clinical phase I as well as the requirements for preclinical documentation. Last but not least, you will be able to assess when Scientific Advice on non-clinical issues is appropriate.

After Day III (optionally bookable), you will be familiar with the preclinical specifics regarding biochemicals and monoclonals too.

Your benefit

As part of this compact course, our experts will teach you how to move quickly and efficiently from drug screening to first-in-human studies.

Here you will receive first-hand regulatory and practical expertise.

On day I+II our experts will share their know-how in the field of small molecules with you, on day III the focus will be on biochemicals and monoclonals.

Detailed programme

Day I: 09:00 am - 5:30 pm - seminar
Day II: 09:00 am - 5:15 pm - seminar
Day III: 09:00 am - 12:45 pm - seminar
You may dial in 30 minutes before the training starts.

Opening and introduction round


Dr Volker Blust

Preclinical sub-areas: The Basics

Dr Elke Stahl

Regulatory framework

Dr Meike Harms

Formulation development

Dr Volker Blust

Project management: Speedily and cost-consciously through the preclinical phase

Dr Volker Blust

Preclinical study program: Pharmacology/Pharmacokinetics and Toxicology (Part I)

End of day I


Dr Volker Blust

Preclinical study program: Pharmacology/Pharmacokinetics and Toxicology (Part II)

Dr Lutz Wiesner

Current preclinical questions on the clinical trial

Dr Volker Blust

From the test item to the investigational medicinal product

Dr Volker Blust, Dr Lutz Wiesner

Case studies: Study program

Dr Volker Blust

From the test item to the investigational medicinal product

Dr Lutz Wiesner

Early regulatory documentation: IB, CTA, IMPD

Dr Volker Blust

Scientific Advice and early contact with authorities

Dr Bernd-Bodo Haas

Preclinical safety evaluation: Requirements according to ICH S6

End of day II


Dr Matthias Germer

Protein analytics in preclinical development

Dr Bernd-Bodo Haas

Special case biosimilars

Dr. rer. nat. Bernd-Bodo Haas

Preclinical requirements for first in humans
  • Concept of preclinical models
  • Determination of the starting dose
  • Risk assessment

Dr Bernd-Bodo Haas

Special case biosimilars

End of online training


More information

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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