New amendments of Critical parameters in Canadian Clinical trials

Why Should You Attend:
With the growth of the Pharmaceutical and Biotechnology industry, ethics regulations become more and more complicated. To protect safety and liberty of clinical trial participants some of the ethics regulations changed in the last years. Also, concerns for patient's confidentiality and privacy brought some other changes in the regulations.

This webinar presentation will help you to understand the last changes that occurred in Canadian ethics regulations.  It will clarify for sites and sponsors how to ease the ethics process and how to get more quicker ethics approval. Participant will understand how to apply the last changes in ethics regulation in the day-to-day work.

Every member of the study team and site staff participating in the clinical trial plays an important key role. Knowledge of ethics regulations will ensure quicker ethics approval, no audit findings, speeds up the process for new drugs approval and decreases the costs to sponsors.

Areas Covered in the Seminar:

• New ethics regulations in Canada.
• Role and responsibilities of clinical trial staff.
• Key aspects of the role and key players involved the ethic process.
• Preparing protocol submission.
• IND safety submissions.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Clinical trial sponsors study team
• CROs study team
• Study managers, Clinical team leads, CRAs
• Principal investigators, site managers and study coordinators
• Regulatory Compliance Associates and Managers
• Ethics liasons

Instructor Profile:
Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries.

He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.