Clinical Research Web-based Seminars

Struggling to break into Clinical Research Informative webinar about the clinial research professions and the ways to break into the clinical research field. The webinar describes the pharmaceutical industry now and the future of the industry, the CRA job, skills and personality and how to break in the clinical research field. The session is live, so you can ask questions and get answers from the presenter, an experienced clinical  more...

Clinical Research Associate ( CRA ) and Clinical Research Coordinator ( CRC ) Online Training Program ...Clinical Research Associate and Coordinator Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Associate or Clinical Research Coordinator. The content of the  more...

Personalized Online Clinical Research Training for Clinical Research Professionals The content of the Online Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Professional. The course can be personalized so that it fits your requests.  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectations - Webinar By Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...agement of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. See why AEa ™s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/ his charge. Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... Why should you attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important. Areas Covered in the Session: * What doe the FDA look at when Auditing/  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel .... * Ensure availability of suitable non-clinical and clinical research data (eg Phase 1, phase II) information to justify carrying out this clinical study * Prepare outline of the protocol * If the study is carried out in EU obtain the EUDRACT number in accordance with the Clinical Trial Directive requirements * Start to prepare the outline plan for the study using the work  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...ted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Areas Covered In the Seminar: * Discuss how QA differs from QC and who is responsible for each *  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result  more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel ...onent to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear communication regarding the ICF content to potential subjects can result in detrimental consequences to the process that can ultimately affect  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug  more...