2024-10-14 2024-10-14 , online online, 1,890 € plus tax Dr. Volker Blust https://www.forum-institut.com/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 + 21001

Webcode 24122470

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

09-11/12/2024

09-11/12/2024

Period

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
Venue

online

online

Fee
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
  • Regulatory framework
  • Delimination issue
  • Drug candidate selection
  • (Safety-)Pharmacology
  • Pharmacocinetics - ADME
  • Toxiciology and examples

Dr Volker Blust

Regulatory framework
  • Preclinical-related guidelines, e.g. ICH M3, S6, S9 und ICH S7A/S7B
  • Guideline on risk mitigation for first in human and early clinical trials
  • Current challenges

Dr Meike Harms

Formulation development
  • Application routes and formulation
  • Pre-formulation
  • API issues and solution paths
  • Transition into clinics

Dr Volker Blust

Project management: Speedily and cost-consciously through the preclinical phase
  • Project steps and phases
  • Contact to development companies, contract laboratories, CROs
  • First-in-human: Preparation; challenges; planning

Dr Volker Blust

Preclinical study program: Pharmacology/Pharmacokinetics and Toxicology (Part I)
  • Required data for Phase I: Study types, duration, design
  • Avoiding common pitfalls

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
  • Guidelines/guidance documents - important changes
  • Preparation of case studies

Dr Volker Blust, Dr Lutz Wiesner

Case studies: Study program (Part I)

Dr Volker Blust, Dr Lutz Wiesner

Case studies: Study program (Part II)

Dr Volker Blust

From the test item to the investigational medicinal product
  • Quality requirements for the test item for GLP studies
  • Product analytics
  • Starting dose rate for various product types

Dr Lutz Wiesner

Early regulatory documentation: IB, CTA, IMPD
  • Where do I find the requested requirements?

Dr Volker Blust

Scientific advice and early contact with authorities
  • Scientific advice on non-clinical questions
  • Timing coordination: Quality - toxicology - clinic
  • National advice or EMA

End of day II
  • Scientific advice on non-clinical questions
  • Timing coordination: Quality - toxicology - clinic
  • National advice or EMA

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 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

09 - 11 December 2024

Booking day 1+2+3

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.

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