2024-05-25 2024-05-25 , online online, 1,890 € zzgl. MwSt. Dr. Volker Blust https://www.forum-institut.de/seminar/24122470-preclinical-development-from-bench-to-first-in-human/referenten/24/24_12/24122470-seminar-pharma-preclinical-development-praeklinik-kompakt_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 development - Präklinik kompakt

Preclinical development:
From bench to frist in human

- Online training -

Benefits
  • Different point of views
  • Practical knowledge for direct implementation
  • Case studies/practical activities
  • Officially certified according to ISO 9001 +
  • Wir befolgen die IMI-Qualitätskriterien

Webcode 24122470

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

09-11/12/2024

09-11/12/2024

Zeitraum

Day I: 09:00 am - 05:30 pm - Online seminar
Day II: 09:00 am - 05:15 pm - Online seminar
Day III: 09:00 am - 12:45 pm - Online seminar
You may dial in 30 minutes before the training starts

Day I: 09:00 am - 05:30 pm - Online seminar
Day II: 09:00 am - 05:15 pm - Online seminar
Day III: 09:00 am - 12:45 pm - Online seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
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 - 05:30 pm - Online seminar
Day II: 09:00 am - 05:15 pm - Online seminar
Day III: 09:00 am - 12:45 pm - Online 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, Dr Lutz Wiesner

Case studies: Study program (Part I)

Dr Volker Blust, Dr Lutz Wiesner

Case studies: Study program (Part I)

Dr Volker Blust

From the test item to the investigational medicinal product

Dr Volker Blust

Scientific Advice and early contact with authorities

End of day II


Dr Bernd-Bodo Haas

Preclinical safety evaluation: Requirements according to ICH S6
  • Biotech products: What are the regulatory requirements?

Dr Matthias Germer

Protein analytics in preclinical development
  • Peculiarities of proteins
  • Formulation development
  • Analysis for formulation development
  • How to deal with impurities and process changes

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
  • Which data must also be collected for biosimilars?

End of online training


Workshops

09 - 10 December 2024

Booking day 1+2

Montag, 09.12. - 09:00 bis 17:30 Uhr
09 - 11 December 2024

Booking day 1+2+3

Montag, 09.12. - 09:00 bis 17:30 Uhr

More information

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.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

Recommendations

GxP-Regulated Archiving

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration...

24.09.2024, Online
Details
Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable i...

10. - 11.09.2024, Online
Details

Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, gain not just a b...

06. - 07.06.2024, Online
Details

Biopharmaceuticals

LAST CALL! - CANCELLATION DEADLINE: 07.06.2024 - The compact course with a content focus on the development, production ...

24. - 26.06.2024, Online
Details

Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the strin...

10. - 11.06.2024, Online
Details

Go forward

White paper: "Non-clinical aspects of RNA-based drug development"

The development of RNA-based drugs has increased within the past years and is a promising field of research in the pharm...

Details
White paper:
DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO-Account e-Learning
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality

Testimonials

Teilnehmerstimmen aus Januar 2017
Guter Überblick von regulatorischen und wissenschaftlichen Blickpunkten, viele Beispiele


Lockere Atmosphäre, schöne Veranstaltung


Sehr gut vorbereitete und strukturierte Inhalte


Sehr gute Übersicht über die Thematik, inhaltlich sehr gut ausgearbeitet; Zeit für Fragen, angenehmes Tempo