Patent Portfolio Generation and Management

Patent portfolios need to be well managed. Only then a patent portfolio will contribute to the company's revenue and will not be a burden on the company's budget.
Attend this e-learning on patent portfolio management (PPM) and learn from first-hand experience of an experienced patent portfolio manager. You will be shown practical tools and templates. Tools can be scaled and used in different industries. After the e-learning, you will be able to improve your patent portfolio generation and management skills.



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Common Technical Document & eCTD

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.



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CTD Module 3

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.

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EU Variation System & Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.
Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.

This e-Learning was developed in December 2019.



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Introduction to EU Marketing Authorisation

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.



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Market Access for Medical Devices - The NUB process

The landscape of market access in Germany is difficult to understand.This e-learning is designed to give you a broad comprehension of the German healthcare system, market access and reimbursement of medical devices in Germany.
The e-learning is divided into three main modules. The first module introduces market access and reimbursement in Germany. In the second module, you will dive deeper into the German healthcare system and get a general overview of how it works. The third module will go into detail about the NUB (New Investigation and Treatment Procedures) procedure, an important aspect of the German healthcare system that many foreigners may not be aware of. In this module, you will gain valuable insider information on how to successfully get reimbursed for your NUBs in Germany.



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Medical Device Advisor (MPDG)

Our e-learning is perfectly tailored to medical device advisors: Learn which current legal requirements are placed on medical device advisors. The focus of the 5 modules is on the regulatory framework for medical devices in the European Community and the current requirements and duties of medical device advisors. After successful completion of this e-learning, you will be familiar with the legal framework and will be ideally equipped for your day-to-day work as a medical device advisor.



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Reimbursement for the German Healthcare Market

This e-Learning is designed to give you a comprehensive understanding of the different types of reimbursement in the German healthcare market. After a general overview of the topic, reimbursement in the outpatient and inpatient sectors or, in the latter case, the DRG system is highlighted. Reimbursement of digital health applications (DiGA) and health market data research is also part of the e-Learning. As major changes in the German healthcare system are imminent with hybrid DRGs and the new hospital reform, which will have a serious impact on practice, we will also bring you up to date here.


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Stability testing in the ICH-region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

This e-Learning will provide you with:

• knowledge of regulatory frameworks in Europe, the ICH region and the US
• an understanding of the chemical, physical and microbiological factors influencing stability testing, as well as container closure systems and the transportation
• in-depth knowledge of stability study requirements
• the ability to apply bracketing and matrixing
• knowledge of the data needed for extrapolation and defining the shelf life of a product
• an understanding of the impact of changes on stability
• knowledge of the stability specifics of biological products

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German Employment Law

This e-Learning programme helps you understand and implement German Employment and Labour Law.

• Understand the structure and particularities of German employment and labour law.
• Become competent in managing the daily tasks and problems that are related to employment and labour law.
• Understand and make use of the appropriate tools when engaging or dismissing employees, or restructuring your business.
• German key vocabulary is introduced without you having to speak or understand German.
• Get up to date on the latest court decisions relating to dismissal, employment contracts, the Minimum Wage Act and other key topics.

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Digital Transformation

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.



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German Accounting Basics

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.



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IT Performance Management

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;

• budget planning,
• cost accounting and
• activity allocation.

You also receive important information about quality control and success rating, control systems and controlling tools in IT.



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IT-Security Foundation

In order to protect IT efficiently, the three classic goals must be achieved:

• Confidentiality of information
• Integrity of information and systems
• Availability of information and systems

In addition to topics such as attack vectors, this course also provides advice on implementing an IT security strategy, as well as information on IT trends and their impact on IT security.



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Management Accounting (Basic Course)

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.



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Leading agile and resilient teams

When we think of leadership, the experiences of climbers who attempted to climb such famous mountains as Mount Everest are an excellent illustration. While there were many attempts, few succeeded in their missions. Among several differences between these expedition teams, including team size or physical ability, one factor made the biggest difference: Leadership. Effective leadership always reveals a high correlation between high levels of team performance and high coaching skills. In this course, you will learn to coach your teams toward high levels of team performance. Although coaching teams is not rocket science, it requires a systematic approach where you take one step at a time - just like climbing a mountain.



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Successful Negotiation

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.



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Managing Director: Duties and Liabilities in a German "GmbH"

Honestly, do you know the risks of being a managing director of a German 'GmbH'? Are you aware of the possible consequences for your own private property and belongings? Do you know your rights and responsibilities? The purpose of this course is to give you a practice-oriented rendition of all the essential issues and questions which arise. Our speakers will answer all questions regarding your every day work.


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