Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event
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.
During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
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!
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.
Enhance your market access strategy in Europe with our specialized seminar series "Healthcare Systems across Europe" tailored for professionals in the pharmaceutical industry. This program covers the key aspects of healthcare systems in Italy, Germany, the UK, France, and Spain.
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.
- GVP Module XVI Risk minimisation measures (Rev 3) came into force - 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.
Success in generic drug market access and pricing in Europe - register now!
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!
This webcast series is tailored for those seeking to understand market access for medical devices and technology in North and South America through concise, focused sessions, with the added benefit of addressing your specific questions.
This seminar will focus on AMNOG and JCA dossier preparation as well as the German AMNOG procedure in comparison with the EU HTA procedure.
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.
Online seminar on Market Access & Pricing in Europe - this is how you can gain access as a pharmaceutical manufacturer!
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 familiarise you with the data requirements in CTD Module 3.
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
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...).
With our e-learning specially tailored to medical device consultants, you will receive the knowledge essential for medical device advisors - so that you can move about in your everyday professional life with legal certainty!
This e-learning provides a comprehensive understanding of reimbursement in the German healthcare market, covering outpatient and inpatient sectors, digital health applications, and upcoming changes like hybrid DRGs and hospital reform. Stay informed and up-to-date on these significant changes in the German healthcare system.
The e-learning provides a comprehensive understanding of the German healthcare system, market access and reimbursement of medical devices, with a particular focus on the NUB process. Get insider knowledge from our speaker and place your product successfully on the German market.
Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.
During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
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.
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.
The online seminar with details on development, quality, CMC, approval and market access for advanced therapy medicinal products. Secure your place in our virtual seminar via Zoom.
Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.
Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.
Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.
Pharmaceutical industry in transition: The importance of AI for quality & efficiency - Artificial Intelligenge in GxP-/ISO-regulated areas.
Project management in GxP - Managing projects successfully and efficiently in a regulated environment!
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.
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!
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.
The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.190€ plus VAT) - for booking, please contact us!
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.
