Attend one of our free pre-meetings to familiarise yourself with Zoom and the various ways in which you can interact during the event
Four live webcasts à 2 hours every week in March 2022: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
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.
A bi-weekly update on hot topics around data integrity in the pharma world - register now! The training course will be entirely held in English.
Strategic and operational planning for efficient marketing authorisations - Take the chance and discuss your daily business challenges with our experts! The training course will be entirely held in English.
Medical communication in Europe: Hot topics and pitfalls - Three experts will update you on the current requirements. Take the chance and join our online training course via Zoom. The training course will be entirely held in English.
Get your know-how on the requirements for new and existing approvals in Europe during this online training course. Six excellent speakers will share their in-depth knowledge with you and will provide you with practical tipps. Take the chance and join our training via Zoom. The training course will be entirely held in English.
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.
During this summer school 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.
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
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.
CMC requirements in Latin America with focus Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and participate online! This course may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (22092610) (special rate available).
Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.
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 via Zoom.
Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.
Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.
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 and pharmacovigilance at your fingertips!
The online compact course for preclinical beginners with a focus on small molecules and biologics. Take this opportunity to discuss the challenges in your practice with our experts and industry colleagues.
Get your quality-related regulatory update 2022/23 here - Day I: Update from authorities and working parties, day II: Update CMC requirements in non-EU regions, as China, Japan, India, Brazil, Mexico, Russia/EAEU (experts with local know-how). Take the chance and discuss your current daily business challenges with our experts and your colleagues. Both days may be booked seperately!
ATMPs: Quality and risk management - Five experts from industry, consulting and authority will address the specifics of ATMPs/gene therapeutics in terms of GMP, quality assurance and risk management.
Get your know-how on creating and maintaining quality data for biotech products in our online training via Zoom.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
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...).
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 will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed
Do you need detailed know how about management accounting function and tasks? This top e-Learning explains the process of preparing management reports and accounts that provide accurate and timely financial and statistical information required by managers to make day-to-day and short-term decisions.
Digital transformation is solving problems with the best possible technical means. In order to find the right solutions, a fundamental understanding of digital transformation is essential. Use the food for thought and practical examples in this e-learning to identify the improvement potential in your company.
One of the key elements in running any business that uses IT services is the management of IT costs. The company's IT should be used as sustainably as possible and the added value should be demonstrable.
In Germany alone, IT failures and malfunctions cause damage running into billions every year, with the number of attack vectors rising and the threat posed by cyber criminals continuing to grow.
High-quality e-learning for a well-founded understanding of the concept of the Concept of the German Accounting Standards
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
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