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INTRODUCTION

The revision of the ICH-GCP Guideline has come into force on the 14th of June 2017. In fact, the revision maintains the original text from 1996 but adds definitions, clarifications on the existing text and especially adds a comprehensive section on risk-based quality management responsibilities of the sponsor.

In this Interactive GCP Workshop, you will learn about the changes and get an opportunity to better understand the implications of these additions for the quality management system of the sponsor and its suitability for investigator sites in practical terms.

Applying the principles of quality risk management will be the topic of an exercise.

This training is for professionals working in clinical trials (Investigators, clinical study teams or referrals, i.e. clinicians, GPs, study coordinators, study nurses), Clinical Research Coordinators, Clinical Research Organizations (CROs), members of Ethics Committees or Competent Authorities, researchers or other research staff.

The participants will have to pass a test to get the Certificate of Completion.


TRAINING DETAILS:


Date/Time: July 13 / 14, 2021 

Location: Online

Language: English

Online registration: open until Tuesday, July 7, 17:00 (EET) 

Trainer: Ingrid Klingmann, MD, PhD, FFPM, FBCPM- Chairman of European Forum for Good Clinical Practice (EFGCP), EFGCP Consultant & Trainer

Host: Cristina Florescu Moraid, MD, MSc, EuSpLM, MRQA -CEO AVANTYO Institute of Clinical Research

Participation fee: 750 lei / 150 euro (no VAT refund)

Discounts: 5% for over 3 participants and 10% for over 5 participants from the same institution. For assistance please contact us at diana.lupu@avantyo.com, 0726 840 456.


PREVIOUS EVENTS: 


1. Interactive GCP Virtual Training - August 25, 2020 - Click for more details

2. Interactive GCP Virtual Training - September 29, 2020 - Click for more details


Note:

Online event |  The ZOOM details and instructions will be sent a few days in advance, as well as the support material of the course and a protocol synopsis that has to be read upfront to the training not to lose time during the exercise session.

During the online meeting, the participants’ names will be disclosed as they will be split into small groups for an exercise session.

Certificates |  A “GCP-Certificate of Completion” will be issued for you if you pass the test. If you do not pass the test you will receive a “GCP-Certificate of Attendance”. To have a full valid certificate for clinical trials, you need to receive a “GCP-Certificate of Completion”.

After the completion of the course, the certificate will be available to be downloaded from each participant account on www.avantyo.com. 

Discounts and assistance | Please contact us: info@avantyo.com, diana.lupu@avantyo.com, 0726 840 456.

Not sure how to book? Click here for instructions in Romanian.


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Waiting list

If you would like to be placed on a waiting list for the next course or you need something else, please let us know at info@avantyo.com. Do not forget to mention your specific education needs in clinical trials


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Ingrid Klingmann, MD, PhD, FFPM, FBCPM PHARMAPLEX bv, EFGCP, PharmaTrain Federation

Ingrid Klingmann, MD, PhD, European Forum for Good Clinical Practice (EFGCP), Pharmaplex bv, Brussels, has 30 years of practical experience with planning and performance of clinical trials from a sponsor and investigator perspective in the pharmaceutical industry, CRO and academic institution. Through her activities in multi-stakeholder not-for-profit organisations like EFGCP, she gained broad experience in ethical, quality and regulatory challenges in clinical research and possible approaches to solutions.

  • Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in the pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.
  • Since January 2003 she has her pharmaceutical development and site management support consulting company.
  • Dr Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-NET, PARADIGM and ConCEPTION) and with her company in the FP7-funded paediatric LENA project. Her broad professional background as a physician with experience in patient care, clinical development, site management and patient engagement enables Dr Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development to develop new patient-relevant treatments more efficiently.
  • Dr Klingmann is also President of PharmaTrain Federation, the not-for-profit organisation focussing on global standardisation and improvement of post-graduate training in medicines development sciences. She also teaches on different clinical research and regulatory affairs topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.

Schedule

13 / 14 July Available seats 100 / 100 Online EUGCP
28 / 29 September Available seats 100 / 100 Online EUGCP
Participation Fee 150 Euro No VAT refund.
Payment by credit card or bank transfer

Discounts:
• 5% for over 3 participants
• 10% for over 5 participants
No VAT refund. Corporate discounts: 5% for over 3 participants 10% for over 5 participants For more information please contact us at info@avantyo.com or 0726 840 456

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