2021-12-08 2022-11-10 , online online, 1.790,- € plus tax Dr. Volker Blust https://www.forum-institut.com/seminar/22112470-preclinical-compact/referenten/22/22_11/22112470-online-seminar-pharma-preclinical-compact_blust-volker.jpg Preclinical compact

The online compact course for preclinical beginners with a focus on small molecules and biologics. Take this 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 of biologics and biosimilars (Day III)
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 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, you will also know the preclinical specifics regarding biochemicals and monoclonals.
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 med-scientific departments will benefit from this seminar.

Online seminar Pharma - Preclinical compact

Preclinical compact

- Online training -

Benefits
  • Excellent speakers
  • The most important in 2.5 days
  • Practical knowledge for direct implementation
  • Submit your questions prior to the training
  • We follow the IMI quality criteria

Webcode 22112470

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

08. - 10.11.2022

08. - 10.11.2022

Period

Day I: 09:00 am - 5:30 pm - seminarD...

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

online

online

Downloads
Fee
Your contact person

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

The online compact course for preclinical beginners with a focus on small molecules and biologics. Take this 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 of biologics and biosimilars (Day III)
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 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, you will also know the preclinical specifics regarding biochemicals and monoclonals.

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 med-scientific departments will benefit from this seminar.

Detailed programme

Day I: 09:00 am - 5:30 pm - seminar
Day II: 09:00 am - 5:00 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 - Basics
  • Regulatory framework
  • Boundary issues
  • Drug Candidate Selection
  • (Safety) Pharmacology
  • Pharmacokinetics - ADME
  • Toxicology and examples

Dr. Elke Stahl

Regulatory framework
  • Preclinically relevant guidelines e.g. ICH M3, S6, S9 and 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 formulations
  • Preformulation
  • Drug problems & solutions
  • Transition to the clinic

Dr. Volker Blust

Project management: speedily and cost-consciously through the preclinical phase
  • Project stages and phases
  • Contact with development companies, contract labs, CROs.
  • First-in-human: preparation; challenges; planning

Dr. Volker Blust

Preclinical study programme: Pharmacology/Pharmacokinetics and Toxicology (I)
  • Data required for Phase I: study types, duration, design
  • Avoid stumbling blocks

End of day I


Dr. Volker Blust

Preclinical study programme: Pharmacology/Pharmacokinetics and Toxicology (II)
  • Data required for Phase I: study types, duration, design
  • Avoid stumbling blocks

Dr. Lutz Wiesner

Current preclinical questions on the clinical trial
  • Guidelines/Guidance documents - important changes
  • Preparation of the case studies

Dr. Volker Blust, Dr. Lutz Wiesner

Case studies: Study programme

Continuation: Case studies: Study programme

Dr. Volker Blust

From the test item to the investigational medicinal product
  • Meet quality requirements for the test item for GLP studies
  • Product analysis
  • Starting dose for different product groups

Dr. Lutz Wiesner

Early regulatory documentation - IB, CTA, IMPD
  • What requirements can be found where?

Dr. Volker Blust

Counselling interview and early contact with authorities
  • Scientific advice on non-clinical questions
  • Time coordination: quality - toxicology - clinical
  • National advice or EMA

End of day II


Dr. rer. nat. Bernd-Bodo Haas

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

Dr. Matthias Germer

Protein analytics in preclinical development
  • Peculiarities of proteins
  • Formulation development
  • Analytics for formulation development
  • Dealing with impurities and process changes in the preclinical phase

Dr. rer. nat. Bernd-Bodo Haas

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

Dr. rer. nat. Bernd-Bodo Haas

Special case biosimilars
  • What data must also be collected for biosimilars?

End of online training


More information

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

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

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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.

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