With this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.
With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.
Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success
RNA-/DNA-based drugs: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.
LAST CALL! - CANCELLATION DEADLINE: 03.09.2024 - Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!
Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.
LAST CALL! - CANCELLATION DEADLINE: 09.09.2024 - Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.
An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.
This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.
FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.
CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.
Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way.
This online conference addresses the digitalisation of labelling, the transformational potential of emerging technologies like AI and how pharma companies need to prepare to implement these technologies in the regulaory affairs context.
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!
Get your know-how on creating and maintaining quality data for biotech products in our online training.
Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Book now!
Development of inhaler/inhalants/pulmonal drugs: An overview of the regulatory/quality (CMC), device and clinical requirements - what is relevant for approval? what's "new"? Four proven experts will discuss all relevant aspects with you and your colleagues from the industry.
Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!
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.
Outsourcing of activities, tasks or positions in regulatory affairs and pharmacovigilance is often standard practice. In this seminar, you will not only learn all you need to work with service providers, but also how to set up and monitor an effective vendor oversight programme in practice.
Preclinical 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.
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.
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
Will you be involved in the implementation and sustainable maintenance of the quality management system in your pharmaceutical company in the future? Our experts will provide you with the essential understanding of the subsystem of good manufacturing practice in this seminar. Also suitable as an update for experienced specialists.
This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.
This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.
