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April 2021

How to Conduct Clinical Investigations with Medical Devices

Basel, April 20 @ 10:00 am - April 21 @ 1:30 pm CEST
Virtual Classroom, remotely via digital platform Switzerland

In the EU member states medical devices were regulated completely different to pharmaceuticals due to different histories, economic reasons and a distinct mode of action. With the new EU medical device regulation the need and requirements for clinical data increased significantly. Consequently, the regulations for conducting clinical trials with medical devices were completely updated. The objective of this training is the communication of current legal, ethical and administrative requirements as well as quality, scientific and practical aspects which are necessary for the conduct of clinical trials with medical devices. This training will support the trainees to increase the quality of your clinical studies in accordance with the regulatory requirements.

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Virtual Classroom: From Molecule to Medicine – An Introduction to Clinical Trials including ICH-GCP

Basel, April 26 @ 9:00 am - April 29 @ 12:30 pm CEST
Virtual Classroom, remotely via digital platform Switzerland

This interactive course provides the perfect introduction to the different phases of drug development, clinical trials and complexity of these fields. The combination of trainer interaction, information sharing, exercises and quizzes guarantee a solid introductory understanding of the topic.

It has been designed for newcomers to the industry, clinical research personnel with up to 2 years experience, those returning to “the sharp edge” of Clinical Operations, scientists working in related areas.

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May 2021

Virtual Classroom: Project Management for Clinical Trials

Basel, May 3 @ 9:00 am - May 4 @ 5:00 pm CEST
Virtual Classroom, remotely via digital platform Switzerland

The aim of this virtual training workshop is to ensure you gain a comprehensive understanding of the tools and techniques of project management and clinical trial management and how they can be applied straight away to your own clinical research projects in the workplace.

It is specifically designed for Clinical Trials Professionals including Clinical Trial Coordinators who want to develop effective clinical trial management and clinical trial project management skills.

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Virtual Classroom: Understanding Pharma Market Access

Basel, May 18 @ 9:00 am - May 19 @ 12:30 pm CEST
Virtual Classroom, remotely via digital platform + Google Map

The definition of Market Access is the process to ensure that the right patients who would benefit from a medication, get rapid and maintained access to the medication, at the right time. These days, both clinical effectiveness and 'value for money' are essential and pharma companies must navigate an increasingly complex re-imbursement landscape to make sure the product reaches the patients for whom it is intended. This course provides an introduction to the dynamics and challenges of Market Access in assuring pharmaceutical brands reach the patients.

It will provide those active in, or working with the Healthcare Industry, an introduction to the Market Access dynamics and challenges and is especially useful to those who want to know what Market Access really is! It has been designed for professionals working in the pharmaceutical industry, particularly those in Drug Development, Regulatory Affairs, Medical Affairs who want to learn about the role Market Access plays in providing access of pharmaceutical brands to patients.

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June 2021

Virtual Classroom: Leadership Skills for Pharmaceutical and Biopharmaceutical Professionals

Basel, June 3 @ 9:00 am - June 4 @ 5:00 pm CEST
Virtual Classroom, remotely via digital platform Switzerland

This comprehensive course will introduce you to the core concepts of what makes an excellent leader in the pharmaceutical industry – and how to apply the different skills of leading your staff or team to maximise results. You will become competent and familiar in a range of well-recognised leadership techniques, which you will then go on to use on a daily basis when you return to the workplace, enabling you to perform at a higher level.

It is specifically designed for pharmaceutical and biopharma professionals, will be relevant for existing leaders/managers who wish to enhance leadership skills to a higher level, as well as those new to or aspiring to a leadership/management role.

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Virtual Classroom: Effective Vendor Management and Oversight in Clinical Research

Basel, June 15 @ 9:00 am - June 16 @ 12:30 pm CEST
Virtual Classroom, remotely via digital platform Switzerland

This course is designed for those working/interacting with vendors to deliver your clinical trials. How do you ensure you manage them to optimise your clinical trial delivery? What is required for compliant vendor oversight? What could put you at risk of inspection findings? Do you require a governance system with your vendors? How should you implement this for your outsourcing model and how will it add value? What is the best approach to maintain healthy business relationships when outsourcing? How do you drive performance transparency through use of metrics?

It is aimed at Clinical Development Staff, including those working in Clinical Outsourcing, Contracts and Outsourcing, Clinical Quality Assurance, Clinical Quality Control, Clinical Operations, Vendor Management, Global QA/Compliance and Regulatory Affairs.

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October 2021

Overview of the New EU Clinical Trial Regulation

Basel, October 27 @ 9:00 am - 5:00 pm CEST
CTC Office, Münchensteinerstrasse 41
Basel, Basel-Stadt 4052 Switzerland
+ Google Map

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC).  Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submitting clinical trial information through a single point of entry. The go-live of the centralised clinical trial portal is scheduled for December 2021.

This course is ideal for anyone requiring an overview of the EU Clinical Trial Regulation and changes for EU trials. It will provide essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

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Project Management for Clinical Trials

Basel, October 28 @ 9:00 am - October 29 @ 5:00 pm CEST
CTC Office, Münchensteinerstrasse 41
Basel, Basel-Stadt 4052 Switzerland

The aim of this training workshop is to ensure you gain a comprehensive understanding of the tools and techniques of project management and clinical trial management and how they can be applied straight away to your own clinical research projects in the workplace.

It is specifically designed for Clinical Trials Professionals including Clinical Trial Coordinators who want to develop effective clinical trial management and clinical trial project management skills.

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November 2021

Clinical Statistics for Non-Statisticians: Everything you need to know – in a day

Basel, November 2 @ 9:00 am - 5:00 pm CET
CTC Office, Münchensteinerstrasse 41
Basel, Basel-Stadt 4052 Switzerland

In modern global pharmaceutical companies it is becoming increasingly important for non-statisticians to understand the value and application of statistics in order to maximise the value of the data. This course is designed for professionals working in the pharmaceutical industry with no or little previous knowledge of statistics.

The objective of the course is not to teach how to become a statistician, but to help to work with statisticians, ask them the right questions and get the maximum value when reviewing statistical output.

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Introduction to Clinical Research

Basel, November 17 @ 9:00 am - 5:00 pm CET
CTC Office, Münchensteinerstrasse 41
Basel, Basel-Stadt 4052 Switzerland

This course offers a perfect introduction to understanding the complex process of drug development and most relevant tasks and responsibilities within the clinical research setting.

It is designed for those new to or with little experience in clinical research, those in supporting roles and departments or those seeking an overview or needing basic training of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research.

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