This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type.
Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
This e-Learning was developed in July 2018.
Module 3 is an essential part of the CTD. It presents data on the quality of the drug substance and drug product. But what data is required? How should Module 3 be structured? These are the topics of our e-learning programme.
In this e-Learning you will:
learn that Module 3 is divided into drug substance and drug product parts
take a detailed look at the individual subchapters, their meaning and special requirements
get to know what data is essential for the respective subchapters and why
and learn the roles of the ASMF and CEP, and how to integrate them into Module 3.
Do you need practical expertise in editing essential marketing authorisation documents and compiling an eCTD?
Do you need to make a baseline submission and thus seek practical advice?
This e-Learning consisting of three recorded webcasts will show you step by step how to develop the relevant documents, compile them and submit an eCTD.
Learn all about eCTD submissions at your own pace, anywhere and at any time.
Acknowledgement: These webcasts were recorded in the course of the 'eCTD in the Middle East' live webcast series in April 2019.
This e-Learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.
This e-Learning was developed in May 2018.
This recorded webcast series focuses on the main legal challenges in regulatory affairs. Participants will get a thorough understanding of the legal impact of processes in the marketing authorisation phase as well as throughout the life cycle.
It is intended for regulatory affairs professionals in pharmaceutical companies. It will also benefit legal affairs staff, familiarising them with legal challenges in regulatory affairs.
This e-learning programme 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.
Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.
This e-Learning was developed in May 2018.
This e-Learning imparts broad and practical knowledge about all the essentials of European pharmacovigilance in four, eight or 12 recorded webcasts.
This e-Learning consisting of three, eight or twelve recorded webcasts, will build basic knowledge of pharmacovigilance obligations and you will understand what responsibilities are relevant to you. The regulatory basis, important definitions and tasks of drug safety are developed step by step.
The introductory e-Learning will inform you about general aspects, chances and issues of SME-Finance in Germany. You will learn about the main financing instruments and most common collateral used in SME-Finance. You will gain practical knowledge about the current market environment and a strategic approach how to work successfully with SME. Finally you can verify your analytical skills in credit risk analysis.
In this e-Learning you will be introduced to backgrounds and the history of the blockchain technology. From this basis, it is much easier to grasp the technological foundations of the blockchain as laid out in the seminar. Therefore, you will be able to understand the basic needs of a blockchain, its applications like smart contracts and especially, its limits.
In order to remain competitive in the future, there are a few requirements to fulfill. Among other things, the range of services must be embedded in a digital system, communication and distribution channels must be digitised and constantly re-opened. During this e-Learning, you will acquire an elementary understanding of what digitisation means and which business perspectives open up through digital transformation. Create understanding for the connections of the aspects of digital development.
This introductory e-Learning will inform you about all the important obligations and challenges in german accounting. You will learn about the procedures in Germany and about the data and documents required for group accounting.
Moreover, you will gain practical knowledge about the Revenue Recognition for a product and the structure and submission of an electronic dossier.
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 addition to get to know the main tasks of an IT controller;
cost accounting and
You also receive important information about quality control and success rating, control systems and controlling tools in IT.
Management Accounting is concerned with providing appropriate financial information to managers which then facilitates informed business decisions, better planning and improved performance and control. This e-Learning provides a comprehensive overview of the function, tasks, possibilities and limits of management accounting. It provides detailed knowledge and understanding of budgeting, planning and reporting in practice and application problems. You will learn, apply and analyze established techniques for the evaluation and interpretation of management accounting. In addition, you will also learn how to communicate financial measures effectively and appropriately.
This online course focuses on positive negotiation. Why? Well, we have all heard of the 'Win-Win Idea': the challenge is achieving the desired win-win outcome. This course will provide you with many practical tips and tactics that can be applied to a variety of situations. You will feel more confident and be more decisive in difficult negotiations, and thus achieve better results.
Hans Verheijke, a recognised expert, will share his international experience in negotiation and personal coaching.
Are you considering General Data Protection Regulation (GDPR) compliance of a specific organisation? This e-Learning will help you gain an understanding of the GDPR and its implications for businesses that process personal data of employees, customers, prospective customers or other data subjects. It will also identify the steps you will need to take to become GDPR compliant, and familiarise you with the following topics:
Legal basis to process
Data transfer to third countries and third country controllers/processors
The obligation to inform, records of processing activities and data protection impact assessment
TOMs, data protection by design and by default, commissioned data processing and joint controller