Aghadeer Asadi

Highly motivated and driven individual , experienced Pharmacist , I also bring regulatory affairs experience in medical devices, with a solid background in regulatory submissions, compliance, and product approval processes , enthusiastic and ambitious , always looking for opportunities to learn and grow, and I am excited about the prospect of working with a team of experts who share my passion.

Course Certificate on Clinical Trial Regulation EU 536/2014 in Clinical Research

where i learned to :

• Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EU
• Understand why changes to the Directive 2001/20/EC were made
• Understand the timeline for CTR introduction and transition period
• Learn the essential definitions of terms under the CTR
• Understand how the Clinical Trials Information System (CTIS) is set up
• Understand the submission process of clinical trials in the CTIS
• Understand the validation, assessment and decisions process of clinical trials under the CTR
• Learn the process to submit a Substantial Modification of the protocol
• Learn the process to submit a new Member State in an ongoing study
• Identify the safety and other reporting obligations
• Grasp the risks and challenges associated with the CTR in sponsor organizations
• Prepare a high-level submission planning under CTR

Course Certificate in Good Clinical Practice ICH GCP for Clinical Research where i gained understanding of:

• The International Council for harmonization.
• Aims of ICH
• How was ICH established
• The importance of ICH.
• Groups working within ICH
• Efficacy Guidelines
• What are Good clinical Practices (GCP)
• The link between ICH and GCP

• Painting , Poetry Recitation , Pencil sketching , cooking