Preclinical development: From bench to first in human - Regulations, data and study programs, transition to Phase I, small molecules and biologics - Webinar von FORUM Institut für Management GmbH

- 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 biosimilarsPreclinical 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.

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.

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.