July 31, 01 & 02 August 2024
Dr. Len Pattenden
Advanced Training in Biopharmaceutical Manufacturing -CMC Masterclass

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.

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August 6 & 7, 2024
Dr. Ralp Nussbaum
Update on ICHQ14 and ICHQ2 - Analytical LifeCycle Management, Validation and Transfer of Analytical Methods

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.

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August 13, 14 & 15, 2024
Dr. Len Pattenden
Advanced Training in Biopharmaceutical Technology Transfer

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.

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September 2 & 3, 2024
Dr. Klaus Rose
Pediatric Drug Development Masterclass

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.

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September 4 & 5, 2024
Richard Brady
Pharma Contract Drafting Entry Level - Europe

The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals, working in the for the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing agreements for medicines and vaccines.

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September 10 & 11, 2024
Dr. Len Pattenden
Regulation, Quality & Compliance in ADC Manufacturing - Masterclass

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

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September 16, 17, 18 & 19, 2024
Richard Brady
Pharma Contract Drafting Advance Level - Europe

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.

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September 23 & 24, 2024
Phil Griffiths
Advanced Enterprise Risk Management

The turmoil in the world is intense– with unimaginable impact leading to increasing public unrest, volatile stock markets, natural disasters of a scale thought unimaginable, and world economic uncertainty. In this time of global uncertainty how do you steer a course through these difficult waters? The answer is to recognise the only real link between all these events – RISK – and then to try to anticipate, manage and then deal with these at an enterprise level.

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7 & 8 October, 2024
Phil Griffiths
Method Validation Entry Level Europe - Masterclass

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.

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10 & 11 October, 2024
Phil Griffiths
Method Validation Entry Level US - Masterclass

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.

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16, 17, 18  & 19 October, 2024
Phil Griffiths
Pharma Contract Drafting Entry Level - US

The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals, working in the for the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing agreements for medicines and vaccines.

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05, 06, 07 & 08 October, 2024
Phil Griffiths
Pharma Contract Drafting Advance Level - US

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.

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