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Press Release > Compliance4All to organize webinar on “How to Correctly Submit Pharmacogenomics Data for Faster

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(Free Press Release) Learn how to Correctly Submit Pharmacogenomics Data for Faster Approval by the Agency.

Press Release > Compliance4All to organize webinar on “How to Correctly Submit Pharmacogenomics Data for Faster


      

Press Release Fremont, CA: Compliance4All, a leading provider of cost-effective professional trainings for all the areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “How to Correctly Submit Pharmacogenomics Data for Faster Approval by the Agency, and What to Expect from the Regulatory Agencies in the Near Future”, on July 5. Angela Bazigos, CEO of Touchstone Technologies Inc., will be the speaker at this webinar. Please visit https://goo.gl/bXuaiK to register for this webinar.
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Come July 5, and Compliance4All will be hosting a webinar on the important area of how to correctly submit pharmacogenomics data for faster approval by the FDA, and what to expect from the regulatory agencies in the near future. Why is this learning important? Exploring pharmacogenomics a bit may provide the answer:

Broadly, pharmacogenomics concerns the study of the extent to which genetic variation influences the differences in humans to drug response. This field, which has evolved substantially in the post-genomic era, promises to make drug administration more efficacious and reduce the toxicity of its side effects and other undesirables. It has the potential to fundamentally alter the mode of generalized drug administration that we have all been used to for centuries.

As pharmacogenomics advances, it can make medicine more personalized and reduce, and eventually eliminate mass, blanket therapies. As it develops, it is likely that it can pinpoint the exact suitability of a drug, the threshold at which to fix the dosage based on individual, genetic parameters, and do many other things that medicine as we know now has not been able to. Press Release

Dealing with ever changing regulations
Yet, like all other evolving disciplines, pharmacogenomics has its limitations, precisely because it is evolving. The foremost difficulty with this field is the one concerning regulation. How does one regulate an ever-changing area? Be that as it may; it is important for anyone working in the area of pharmacogenomics to understand the current regulation in this field from the FDA. This is because it is mandatory for any pharmacogenomics company to comply with the existing regulations from the FDA in the US, and with other regulatory agencies elsewhere.

Exploring the regulatory aspects of pharmacogenomics data
Knowledge of the regulatory aspects of pharmacogenomics is the learning a webinar from Compliance4All is offering. The speaker at this webinar, Angela Bazigos, who brings over 40 years of experience in the life sciences, healthcare and public health services; will show participants the ways of understanding the agency expectations and explain how to correctly submit pharmacogenomics data for faster approval by the agency. Given the fast-changing nature of these regulations, she will also offer insights into what to expect from the regulatory agencies in the near future.

She will offer understanding of how to comply with the FDA regulations, which will help win approval for the submitted product, since properly adhering to the submission criteria and method of pharmacogenomics data can impact the business. An important aspect that she will offer clarity on is upcoming regulations on the re-imbursement of the genomic tests. Press Release


Angela will cover the following areas at this webinar:
•    What is Pharmacogenomics (PGX)
•    How is it used in drug development?
•    Why talk about regulation
•    Who regulates industry activity in this area
•    Guidance Documents
•    How does the FDA harmonize with other agencies that regulate PGX?
•    Key Challenges for Regulated Industry
o    Validating Biomarkers and submitting genomic data to FDA
o    Getting Rx/Dx development in synch
o    Uncertainties about re-imbursement
o    Ensuring adequate consent for use of samples, including genomic testing
•    How to ensure that your PGX data is accepted by the FDA and other regulatory agencies
•    What is the outlook for the FDA and PGX.




Press Release > Compliance4All to organize webinar on “How to Correctly Submit Pharmacogenomics Data for Faster

Source: Press Release

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