Golden rules for Sponsor: Handling of Investigational Medicinal Products
PharmaGCP
Center for Knowledge and Quality in clinical research
Welcome to PharmaGCP
Knowledge and GCP training
In order to obtain and maintain your knowledge within clinical research, you can use PharmaGCP through these options:
- Online basic GCP training and examination. Get certified at your convenience. Our online training materials are interactive and efficient and high quality. The content of the training meets the basic requirements as defined by TransCelerate.
- Advanced GCP training or refresher; the training content will be tailored to the specific needs.
- Simple and clear golden rules for different roles in clinical trials. The golden rules also contain practical examples and inspection findings when the rules were not followed.
- Collection of all changes in updated GCP and how to implement them.
- Free-of-charge subscribing for relevant news within clinical research (source from authorities such as EMA, FDA, MHRA)
Quality services
PharmaGCP specializes in GCP mock inspections, GCP/GVP audits, GCP training and QMS. Our specialists have many years’ experience in clinical quality area such as GCP inspector, auditor, clinical quality assurance manager.
Our mission is to deliver services of the highest quality and effectiveness.
News & Articles
EU Clinical Trials Regulation 31.Jan.2023
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into force from 31 January 2023. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. The EU...
EMA consults on medical devices in combination products_Deadline 31.Aug.2019
The European Medicines Agency (EMA) has released a draft guideline on the medical device quality requirements for drug–device combinations (medicines that include a medical device). The guideline (dated 29 May 2019) addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular that...
First EMA guidance on new rules for certain medical devices
EMA has recently published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices . The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to...
FDA draft guidance on drug development for rare diseases
On 1st of Feb. 2019 the FDA announced the availability of draft guidance “Rare Diseases: Common Issues in Drug Development“. This guidance revises and replaces the previous draft guidance of the same name from 2015. Comments and suggestions regarding this draft document should be submitted...
How to identify lack of sponsor oversight?
The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out in accordance with the protocol, written agreements, GCP and local requirements. Especially, when the trial tasks are outsourced to different CROs/vendors at the same time,...
Basic GCP training
Get trained and certified at your convenience.
Advanced GCP training and workshop
The content will be tailored to business needs.
Quality and audit
Keys to sustainable success:
Quality – Compliance and Efficiency
Customers’ feedback on GCP training, provided by PharmaGCP:
Below are examples of feedback from face-to-face training:
Life Science company in Denmark:
It was a very good, relevant and interactive training. There was positive feedback from all participants.
One participant said: I expected 3 boring hours with GCP rules etc., but was so surprised that the training is so relevant to my daily work, so it is far from boring. I already look forward to a refresher training next time.
Pharmaceutical company in Macedonia:
The advanced GCP training was top-scored in all topics; sponsor responsibilities, lab requirements, risk management, risk based monitoring, computerised system, safety reporting, IMP, TMF, protocol deviation, CAPA, audit plan and sponsor oversight.
All participants gave feedback that the training was relevant, interactive and easy to follow eventhough the topics were tough and complex. All stated that it was an excellent course, clear presentations and valuable answers to participants’ questions.
Head of Reseach and Development commented that the IMP topic was unclear before the training due to its complexity, but was well-covered and explained during the training, so it is clear now.
Other participants mentioned that the training was so good, because both trainers have so much practical experience, which is really valuable.
Albert Einstein:
Success = Work + Play
PharmaGCP:
Successful business = Knowledge + Quality
Get in touch with us
info@pharmagcp.com
We work closely with you and carry out research to understand your needs and wishes.