Course description
Regulatory Affairs for Clinical Trials - 2-day Training Course by PTI
Through this comprehensive course participants will:
- Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
- Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance and Clinical Trial Data Management including EDC and e-source
- Explore recent developments in clinical trial regulations including FDA requirements
- Achieve successful regulatory inspections
- Gain an understanding of the new EU Clinical Trial Regulation to prepare for the change
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Suitability - Who should attend?
The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.
The programme will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials.
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 4.6
The CTA overview and resources provided were very good. The majority of the content was relevant to the intersection of CT's and Regulations, which is what my work focus is.
The case studies and interactive nature of the course was the aspects I enjoyed the most. I also liked the introduction session.
Expenses
The cost of this training course is £1200 + VAT per participant, which covers tuition and course materials.
In-house Training
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.
I felt the course was very complete. The interaction with the trainer was great and it was good to have an overview on regulatory affairs for clinical trials.