pharmacogenomics, current regulatory efforts to ensure and promote innovations

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.

Description 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 & Strategist.

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.