Qualification course: CMC-Specialist in Regulatory Affairs

This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.

CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. Contact us!

E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.

Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the right seminar for you! Includes updates on (Draft) ICH Q1, (Draft) ICH M4Q(R2), and ASMF topics, as well as information on new regulatory trends such as ICH Q12, reliance, and AI.

The event will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13A + M13B, ICH M4Q(R2), an update on the ongoing discussions on nitrosamine contaminations, and the revision of PACMP, Lifecycle Management.

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

DAS Online-Seminar zu den Themen Entwicklung, Qualität, CMC, Zulassung und Market Access für ATMPs/Gentherapeutika. Profitieren Sie vom Austausch mit langjähring erfahrenen Expert*innen aus Behörde und Consulting/Industrie sowie mit den Branchenkolleg*innen. Jetzt qualifizieren!

Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.

To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.

The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.

CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.

Navigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies, hands-on workshops and peer exchange to tackle the most common stability challenges head-on.

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.

This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.

CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. Contact us!

E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.

Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the right seminar for you! Includes updates on (Draft) ICH Q1, (Draft) ICH M4Q(R2), and ASMF topics, as well as information on new regulatory trends such as ICH Q12, reliance, and AI.

The event will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13A + M13B, ICH M4Q(R2), an update on the ongoing discussions on nitrosamine contaminations, and the revision of PACMP, Lifecycle Management.

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

DAS Online-Seminar zu den Themen Entwicklung, Qualität, CMC, Zulassung und Market Access für ATMPs/Gentherapeutika. Profitieren Sie vom Austausch mit langjähring erfahrenen Expert*innen aus Behörde und Consulting/Industrie sowie mit den Branchenkolleg*innen. Jetzt qualifizieren!

Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.

To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.

The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.

CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.

Navigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies, hands-on workshops and peer exchange to tackle the most common stability challenges head-on.

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.

This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.

CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. Contact us!

E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.

Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the right seminar for you! Includes updates on (Draft) ICH Q1, (Draft) ICH M4Q(R2), and ASMF topics, as well as information on new regulatory trends such as ICH Q12, reliance, and AI.

The event will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13A + M13B, ICH M4Q(R2), an update on the ongoing discussions on nitrosamine contaminations, and the revision of PACMP, Lifecycle Management.

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

DAS Online-Seminar zu den Themen Entwicklung, Qualität, CMC, Zulassung und Market Access für ATMPs/Gentherapeutika. Profitieren Sie vom Austausch mit langjähring erfahrenen Expert*innen aus Behörde und Consulting/Industrie sowie mit den Branchenkolleg*innen. Jetzt qualifizieren!

Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.

To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.

The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.

CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.

Navigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies, hands-on workshops and peer exchange to tackle the most common stability challenges head-on.

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.