pharmacogenomics, current regulatory efforts to ensure and promote innovations by ComplianceOnline


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									Pharmacogenomics: Data, Policies and Personalized Medicine
This 90-minute webinar will help you understand the current landscape of the growing field of
pharmacogenomics and the current regulatory efforts to ensure that the related drugs will not pose
risks for patient safety and promote innovations.


Why Should You Attend:

This 90-minute session will review the new and expected regulations/ technologies and discuss their
effects on the use of pharmacogenomics in industry. We will explain what the policies are, predict
coming regulations and discuss how industry will be affected. We will explore the personalized
medicine landscape in US, EU and globally.

All functional groups who have drugs responsibility or need to understand the basics of
pharmacogenomics and personalized medicine will benefit by participating in this webinar.

Areas Covered in the Seminar:

       Overview of Pharmacogenomics, applications and challenges.
       From Pharmacogenomics to Personalized Medicine.
       PharmacoGenomics Data, genetic tests and Biomarkers.
       FDA(US) guidances and federal initiatives(NIH, CDC, CMS).
       EMEA (EU), Health Canada guidances and global landscape.
       Clinical Genomics data standards (EHR, HL7, ISO, Healthcare).
       Drug/Healthcare industry and pharmacogenomics.
       Pharmacogenomics and Ethical issues.
       Future of Genomics Medicine.

Who Will Benefit:

       Senior Management
       Clinical research leaders & members
       Clinical Scientists
       Regulatory affairs
       R&D and engineering staff
       Risk Managers
       Academic genomics groups
        Compliance Officers
        Privacy Officers
        Health Information Managers
        Medical Office Managers
        Legal Counsel
        Operations Directors
        Medical offices, hospitals, academic medical centers, insurers, business associate
        All related to risk analysis / management, regulatory submissions, and validations

Instructor Profile:

Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Information Advisor, Author &

Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT business
development, eHealth education and social media, Health Information policy analysis. He is certified
on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in FDA/DHHS laws, regulations
(devices, foods, drugs, personalized health).

        Medical Devices Committee Member, Writer at The Food and Drug Law Institute,
        Consultant (Health Informatics/Policies/Standards) at DHS/ONC/HIT, Standards &
        Interoperability Health Information Management Systems Society, Health Level 7(EHR,
        Genomics, mHealth) , small businesses
        Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival His multifaceted
        area of work is in health technology, architecture, policy and decision making.
        In academia (Johns Hopkins, University of Virginia), Kosta researched and published articles in
        archival journals concerning biomedical and chemical informatics.
        In industry (FannieMae, Sysco, MAKROnanoKosmos), Kosta designed systems, managed
        analytics projects, cofounded eHealth business contributing to health, marketing solutions.
        In government (US-FDA/DHHS Commissioner's Fellow), Kosta trained and worked in
        regulatory science, enterprise architecture, standards, and policy, decisions in public health.

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