Upcoming Courses

From Molecule to Medicine - An Introduction to Clinical Trials including ICH-GCP - 27&28 March 2019

Date:
27 & 28 March 2019

Time:
Day 1: 09:00 – 17:00 hrs
Day 2: 09:00 – 17:00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

This highly interactive course with a balance of information, workshops, exercises and quizzes offers a general overview of the drug development process.

It is addressed to 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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Basic Course in Clinical Research - 3 April 2019

Date:
3 April 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

This course is designed for those with little or no experience in clinical research or those seeking an overview of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research.

It is aimed at Clinical Research Assistants, support staff and persons with related functions (eg. IT Support Staff).

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Basics of Pharmacovigilance in Clinical Trials - 9 April 2019

Date:
9 April 2019
If you are also interested in attending workshop II, please contact training@ctcresourcing.com

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

This workshop is designed to provide a solid foundation of Pharmacovigilance (PV) in Clinical Trials. It will introduce the most important terms and definitions, MedDRA (Medical Dictionary for Regulatory Activities) coding, SAE (Serious Adverse Event) management, unblinding processes, SUSAR (Suspected Unexpected Serious Adverse Reaction) submission, and a first glance at a PV database.

Focus is on basic PV topics related to the Clinical Trial setting. The Post Authorisation phase will be covered in the workshop 'Basics of PV Post Authorisation' on Day 2. If you are interested in attending both workshops, please contact training@ctcresourcing.com.

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Basics of Pharmacovigilance Post Authorisation - 10 April 2019

Date:
10 April 2019
If you are also interested in attending workshop I, please contact training@ctcresourcing.com

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

The purpose of this workshop is to introduce Pharmacovigilance (PV) in Post Authorisation. It will provide essential background knowledge on the origin of PV, sources for cases, case assessments in post authorisation, special situations, quality complaints, and case submissions.

Focus is on basic PV topics related to the post authorisation phase. The Clinical Trial setting will be covered in the workshop 'Basics of PV in Clinical Trials' on Day 1. If you are interested in attending both workshops, please contact training@ctcresourcing.com

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Introduction to Pharma Market Access - 29 April 2019

Date:
29 April 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

In an increasingly cost-conscious health care environment, pharma companies must make a thorough case for not only the clinical, but also the economic value of their products. These days, clinical efficacy alone is not enough; both clinical effectiveness and 'value for money' are essential to make sure the product reaches the patients for whom it is intended.

This one day course will provide those active in, or working with the Healthcare Industry, an introduction to the Market Access dynamics and challenges.

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Clinical Statistics for Non-Statisticians - Everything you need to know - in a day - 9 May 2019

Date:
9 May 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

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 as we start right at the beginning with the basics.

It will be non-software focused, but rather understanding the basic statistical concepts, interpreting output and discussing how the knowledge can be applied and integrated efficiently into the job role.

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Effective Vendor Management and Oversight - 18 June 2019

Date:
18 June 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

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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Overview of the New EU Clinical Trial Regulation - 16 October 2019

Date:
16 October 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). It was originally due to come into effect in 2016, however implementation has been delayed until the new portal and clinical trial database have been completed and audited. 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.

This course is ideal for anyone requiring an overview of the EU Clinical Trial Regulation and changes for EU trials.

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Project Management for Clinical Trials - 17&18 October 2019

Date:
17th (Thu) & 18th (Fr) October 2019

Time:
Day 1: 09:00 - 17:00 hrs
Day 2: 09:00 - 16:00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

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

This leading Project Management course is designed for the Clinical Trials Professionals especially those who are experienced in managing complex Clinical Trials, Senior Research Associates.

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ICH GCP Refresher including Inspections, Current Issues and Hot Topics - 24 October 2019

Date:
24 October 2019

Time:
09.00 – 17.00 hrs

Venue:
CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Summary:

This course offers a thorough update of the current understanding and interpretation of Good Clinical Practice including the changes to ICH-GCP E6 R2, current issues and hot topics as well as practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites.

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