The new ICH guidelines Q14 and Q2(R2) give a new new on analytical life cycle management and analytical method validation. With the introduction of the Analytical Target Profile (ATP), the requirements for method validation and method transfer have changed. The new validation guideline ICH Q2(R2) is now additionally oriented towards new methods such as spectroscopy, bioassays and coupled techniques.

The primary objective of PK/PD modeling is the prediction of the time course of the drug effect and its relation to dose and exposure. PK/PD modeling has become a key success factor in drug R&D. This comprehensive and detailed two-day course describes the PK/PD studies from an industrial perspective to achieve a successful regulatory submission.

This CMC Masterclass offers an immersive exploration into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) for biopharmaceuticals. This comprehensive program covers the full spectrum of biologics; from monoclonal antibodies to advanced therapies like nucleic acids and viral vectors as well as cell therapies.

Technology transfer is a critical process in biopharmaceutical manufacturing, facilitating the transfer of processes, technologies, and knowledge between development and manufacturing sites. Through a combination of theoretical learning and practical application, participants will emerge equipped with the knowledge and skills to excel in technology transfer projects and drive innovation in biopharmaceutical manufacturing.

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex and a strong chemistry, manufacturing and control (CMC) strategy is vital due to the complex nature of these therapeutics and history of failures at both early and late stages. This training encompasses a comprehensive understanding of the primary technical and regulatory (FDA and EMA) challenges

The Advanced Level Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals, working in the Bio/Life-Sciences and Pharmaceutical industry sphere, held over 4 consecutive half-day sessions. It will deal with many contractual issues which relate only to these industries although it will also cover wider contract drafting topics.

Although 13 ADCs are approved for treating cancers, an increasing number of ADCs are also being terminated in clinical development due to poor efficacy, limited durability of response, and, most importantly, unacceptable toxicities.. The training course will discuss intelligent strategies for creating best-in-class ADCs, including target choice, linker selection, conjugation methods, and preclinical /clinical efficacy evaluation.

US and EU regulatory authorities demand pediatric studies for new drugs, in the EU within “pediatric investigation plans“ (PIPs).The training on this very controversial topic offers industry professionals essential background knowledge from the perspective of drug development.

The focus of the Signal Management in Pharmacovigilance 3 half days online training will be to provide a holistic and a detailed approach on activities and processes regarding ongoing safety evaluation and review of the benefit risk of medicinal products while performing signal detection and management.During this training participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools.