Val Mikhailovski
Co-Founder and Principal Consultant at BioPharma Clinical Quality www.biopharmaclinical.com | United States
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Val Mikhailovski, as Co-Founder and Principal Consultant at BioPharma Clinical Quality, brings a wealth of expertise in regulatory compliance and quality assurance across a diverse range of therapeutic areas, including Cellular Immunotherapy, CAR-T, Immuno-Oncology, and Gene Therapy. With a robust working knowledge of national and international standards such as GMP, GCP, PV, and GLP, Val has successfully navigated the complexities of regulatory landscapes in North America, Latin America, Europe, Asia Pacific, and Africa. His extensive experience includes conducting comprehensive audits of Investigator sites, clinical laboratories, and contract research organizations (CROs), ensuring that all processes adhere to stringent quality standards.
At BioPharma Clinical Quality, Val leads key projects that focus on enhancing clinical quality and compliance services for vaccines, pharmaceutical products, and cosmetics. His role involves overseeing mock inspections and inspections, which are critical for preparing clients for regulatory scrutiny and ensuring that their operations meet the highest quality benchmarks. Val’s expertise in pharmacovigilance (PV) and safety reporting is instrumental in developing robust systems that mitigate risks and enhance patient safety.
With a deep understanding of drug development processes and regulatory requirements, Val is adept at guiding organizations through the intricacies of IND submissions and validation protocols. His skills in cleaning validation and drug discovery further complement his comprehensive approach to quality assurance. Val's commitment to excellence and his strategic insights make him a valuable asset to BioPharma Clinical Quality, where he continues to drive innovation and compliance in the ever-evolving biopharmaceutical landscape.
Co-Founder and Principal Consultant at BioPharma Clinical Quality www.biopharmaclinical.com in April 2013 to Present
CLINICAL DEVELOPMENT, GCP/PV/GLP QA at Juno Therapeutics, Inc. in November 2017 to March 2019
Sr. Director at PRA Health Sciences in March 2016 to November 2017
Director, Regulatory Quality Assurance Program at Center for Cellular Immunotherapy/Translational Research Program in March 2014 to March 2016
Head at Novartis in April 2009 to May 2012
Associate Director, Global Clinical Quality and Compliance at Novartis in April 2009 to April 2012
Senior Manager at GlaxoSmithKline in November 2002 to April 2009
Manager, World Wide Clinical Compliance at GlaxoSmithKline in October 2003 to March 2008
Program Manager, World Wide Clinical Compliance at GlaxoSmithKline in November 2002 to October 2003
Sr. Auditor at Pfizer Inc in June 2001 to November 2002
Associate Director Regulatory Compliance at Institute for Human Gene Therapy (IHGT), University of Pennsylvania in September 1998 to June 2001
Compliance Manager at Institute for Human Gene Therapy (IHGT), University of Pennsylvania in August 2000 to February 2001
Documentation Manager at Institute for Human Gene Therapy (IHGT), University of Pennsylvania in September 1998 to August 2000
Research Specialist at University of Pennsylvania Health System in June 1995 to September 1999
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Leningrad Institute of Engineering St, M.S.E./B.S, January 1981 to January 1986
University of Pennsylvania, M.S, January 1997 to January 1999
University of Pennsylvania, Master of Science, January 1997 to January 1999
West Chester University West, B.S, January 1992 to January 1994
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GCP
FDA
Clinical Trials
Sop
Pharmaceutical Industry
Clinical Development
Regulatory Submissions
Quality Assurance
CRO
Validation
GMP
Clinical Research
Pharmacovigilance
CAPA
GLP
Drug Development
Vaccines
Regulatory Requirements
Regulatory Affairs
Protocol
GxP
Oncology
Biotechnology
Medical Devices
Infectious Diseases
V&V
Pharmaceutics
21 CFR Part 11
Computer System Validation
IND
Lifesciences
Technology Transfer
Quality Control
EDC
Clinical Operations
Laboratory
Cleaning Validation
Medical Writing
Risk Management
Biopharmaceuticals
Software Documentation
Quality Auditing
Quality System
Clinical Data Management
Immunology
ICH-GCP
Drug Discovery
Cancer Immunotherapy
T Cell Therapy
Life Sciences
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What is Val Mikhailovski email address?
Email Val Mikhailovski at [email protected] and [email protected]. This email is the most updated Val Mikhailovski's email found in 2026.
How to contact Val Mikhailovski?
To contact Val Mikhailovski send an email to [email protected] or [email protected]. (updated on March 12, 2021)
What company does Val Mikhailovski work for?
Val Mikhailovski works for BioPharma Clinical Quality www.biopharmaclinical.com
What is Val Mikhailovski's role at BioPharma Clinical Quality www.biopharmaclinical.com?
Val Mikhailovski is Co-Founder and Principal Consultant
What is Val Mikhailovski's Phone Number?
Val Mikhailovski's phone (***) ***-*121
What industry does Val Mikhailovski work in?
Val Mikhailovski works in the Biotechnology industry.
Val Mikhailovski Email Addresses
Val Mikhailovski Phone Numbers
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