SOPs for Clinical Trials: Regulatory Requirements

Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on June 2 on the topic, “SOPs for Clinical Trials: Regulatory Requirements”. Harold Thibodeaux, a medical research scientist, will be the speaker at this session.

About the webinar:

That those in the field of clinical research are going to be looking at ways to innovate in their research to meet unmet medical needs, especially of rare diseases, is indisputable. The fact of a whopping 4000 percent increase in the number of registered clinical research in just 14 years from 2000 corroborates this view.

For more information or to register for the webinar, please click here.

A couple of points supplement this observation: The FDA has approved as many as 44 drugs in 2014 alone, the highest in 18 years. And, nearly 200,000 studies are currently taking place in 190 countries. These facts, plus the increase in the number of clinical trials of the magnitude pointed to earlier indicate that in the next few years, novel technological approaches will be aimed at the unearthing of hitherto undiscovered molecules.

What do developments of this scale point to? They point to the need for the formulation and of new SOPs and strengthening of existing ones in order to regulate and direct the daily happenings in the industry in which such feverish activity is taking place. SOPs define the standard practices of the clinical groups and ensure their execution on a day-to-day basis in line with federal, state and institutional guidelines.

This webinar will highlight the need for new and modified SOPs in the light of these rapid changes. Although the FDA does not strictly require these SOPs, they find mention in the ICH GCP and HSP guidelines. The speaker will take participants through the elements of these guidelines and regulations.

About the Speaker:

Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. Harold supports projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.

About Compliance4All:

Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.

Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/