training

Clinical Research: Career Opportunities and Regulations

Clinical Research: Career Opportunities and Regulations

translational research
Location:

Leuven, Park Inn by Radisson

Start date:

15 September 2020

Duration:
15 September 2020

General context

The attendees of this session have a scientific background and have an interest in understanding the basics of the current regulatory requirements for clinical trials. A second topic will cover orienting your career in clinical research.

Objectives

After this training, you will:

  • understand the basic concepts of and obtain a clear view on the clinical research regulations and how they came to existence
  • be able to identify what is needed in order to get the required approvals to start a clinical study
  • get familiar with terminology and abbreviations
  • know what the different positions in clinical research are
  • understand the clinical research competency framework
  • see what the best steps are to find a job in clinical research

 

Approach

ECCRT aims for the best return on investment for the participant. Our goal is for trainees to leave the course with the capacity to use the information provided in the most practical way. Our expert trainers always encourage interactivity in the group. ECCRT supports the statement: “You tell me, and I forget. You teach me, and I remember. You involve me, and I learn”.

Event intended for

PhD students, postdocs and staff scientists working at VIB who have an interest in understanding the basics of the current regulatory requirements for clinical trials. We will also address career opportunities in clinical research.

Extra information
  • This training is free for VIB participants.
  • The fee for non-VIB Academics is € 100 for both days (VAT incl).
  • Note that upon no show without valid justification a fee of € 100 will be charged and you will be blacklisted for the VIB training program for 1 year. Click here for more information

Trainers

Marleen Verbeeck

Marleen Verbeeck, is a trainer/coach and has been working at the European Centre for Clinical Research Training (ECCRT) since 2004.

She obtained her PhD in molecular biology at the University of Utrecht in 1990. After fundamental research positions at the universities of Utrecht, New York, Leuven and Maastricht, she changed her academic career in 1995. She gained solid grounding in clinical research, first as a clinical research associate, later as a medical writer combined with a position as trainer.

Marleen enjoys developing, lecturing, evaluating and developing comprehension tests of courses as well as boosting confidence and competence of clinical research professionals with different experience levels from the pharmaceutical, medical device industry and non-profit research organisations.

She has more than 15 years of educational expertise. She is author of scientific papers, clinical trial study protocols (phase I - IV) and clinical study reports. She has experience in medical areas such as : CNS, Gastroenterology, Gynaecology, Rheumathology, Cardiology, Oncology, Orthopaedics and Immonutherapy.

In addition, recently Marleen is also a regulatory consultant on European clinical trial legislation. Acquiring and conveying knowledge has always been her interest throughout her professional career.

Benedikt Van Nieuwenhove

Prof. Dr. Benedikt Van Nieuwenhove obtained his degree in Pharmaceutical sciences from the University of Gent, Belgium in 1991. Between 1991 and 1997 he worked as a quality assurance manager at a laboratory for medical biochemistry & clinical analysis in Gent.  In 1997 he finished his Ph.D. in Pharmaceutical Sciences at the University of Gent in Belgium. 

Since then till 2014 he had been working for Harrison Clinical Research. He started his career as clinical operations manager and general manager of the Benelux operations.

In 2000, he founded their own training Academy, the "European Centre for Clinical Research Training” (ECCRT) and in 2007 he became a member of the Board.

From 2008-2011 he acted as the Vice President Global Operations of the Harrison Clinical Research group. In January 2011, he was elected Chief Executive Officer of Harrison Clinical Research. In that position he was involved in the merge with Synteract to form SynteractHCR. He has been instrumental in integrating the two organisations during 2013 and 2014.

Since its creation in 2000, Benedikt has been the Managing Director of ECCRT.

Having been in the field of Clinical Research for about three decades he has amassed a wealth of knowledge and skills within this field. Over the years he has supported the Pharma Industry as well as other players in the healthcare sector by providing them with the skill sets to deal with the challenges in their job and to make them efficient players in study success.

Since 2016 he is lecturing “Management of Clinical Research” at the Faculty of Pharmaceutical Sciences, University Ghent.

Program

Basics in Regulatory Requirements in Clinical Trials

-

Welcome & introduction

Clinical Research

  • What & why

Rules for clinical research

  • History
  • Declaration of Helsinki
  • ICH-Good Clinical Practice
  • Guidelines & Legislation
-

Coffee break

-

Rules during the life cycle of a clinical trial

  • Getting approcal before starting a clinical trial
  • Rules & documents during an ongoing clinical trials

Inspections:

  • Difference between regular medical practice and clinical trials
  • Non-compliance & consequences
-

Conclusions and Q&A

-

Lunch

Orienting your career in clinical research

-

Welcome & introduction

-

The clinical competency framework

-

Coffee break

-

Mapping of profiles versus positions

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Recommendations for finding a job in clinical research

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Conclusions and Q&A