Diane Barnes Email and Phone Number
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Regulatory and quality professional with diverse background in global regulatory strategy and submissions; quality assurance and compliance; personalized medicine and pharmacogenetics; and project management.Specialties: Regulatory Affairs, Personalized Medicine, Clinical Quality Assurance
Astellas Pharma
View- Website:
- astellas.com
- Employees:
- 11726
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Senior Director Of Regulatory AffairsAstellas Pharma Mar 2022 - Present
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Director Of Regulatory AffairsAstellas Pharma Apr 2017 - Mar 2022
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Associate Director Of Regulatory AffairsAstellas Pharma Nov 2015 - Mar 2017
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Associate Director Regulatory AffairsTakeda Pharmaceuticals May 2011 - Nov 2015Tokyo, Jp -
Associate Director, Regulatory AffairsAbbott 2004 - Jan 2011Abbott Park, Illinois, UsProvide regulatory leadership and strategy for development programs for new drugs including psychiatry, neurology, oncology and renal products. Lead the compilation, review and submission of dossiers to regulatory agencies for INDs and clinical trial applications. Routinely interact with medical reviewers and regulatory project managers at FDA. Lead regulatory subteams and advise global project teams.• Negotiated INDs with FDA for treatment of Alzheimer’s disease, schizophrenia, ADHD, diabetic nephropathy and Clinical Trial Applications with global Health Authorities including FDA, EU, Canada, Russia, Ukraine and South Africa. • Provided strategic regulatory input into preparation of preclinical, clinical, and other technical documentation.• Lead regulatory agency meetings with FDA and PMDA including review and submission of briefing documents and management of other preparatory activities. • Oversaw implementation of EU Clinical Trial Directive. • Participated in the establishment of the Project Management function within Regulatory Affairs. -
Operations Manager, PharmacogeneticsAbbott Apr 2000 - Sep 2004Abbott Park, Illinois, UsResponsibilities included liaison to global project teams to advise on incorporation of pharmacogenetics into clinical development programs and collection of pharmacogenetic samples. Assured quality processes in sample collection, handling and analysis. Advised on ethical issues and interacted with ethics committees to address concerns with protocols and informed consent. Departmental functional responsibilities including capital, functional budgets, and resource estimates.• Chairman, Pharmacogenetics Working Group – 2001-2002. Chaired an international consortium of pharmaceutical companies engaged in pharmacogenetics research. Increased membership 20%, conducted an international symposium in conjunction with DIA (3/5/2002), co-sponsored a workshop with FDA & PhRMA (300 attendees/50% from FDA), published paper on pharmacogenetic considerations regarding informed consent.• Requested to speak on practical and ethical issues to external organizations such as DIA and PRIMR (IRB organization).
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Department Manager, Research Quality AssuranceAbbott Jul 1993 - Apr 2000Abbott Park, Illinois, UsManaged the clinical quality audit function with responsibilities for investigator site, CRO, laboratory, quality systems, protocol and clinical study report audits with 25 direct and indirect reports. Directed development and implementation of training program for clinical research personnel, cross-functional and cross-divisional process improvement projects which resulted in cost savings and greater regulatory compliance including clinical development plan, clinical study report and protocol guideline templates
Diane Barnes Skills
Diane Barnes Education Details
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Northwestern UniversityNeuroscience -
Loyola University Chicago Stritch School Of MedicinePharmacology
Frequently Asked Questions about Diane Barnes
What company does Diane Barnes work for?
Diane Barnes works for Astellas Pharma
What is Diane Barnes's role at the current company?
Diane Barnes's current role is Senior Director, Regulatory Affairs at Astellas.
What is Diane Barnes's email address?
Diane Barnes's email address is di****@****ast.net
What schools did Diane Barnes attend?
Diane Barnes attended Northwestern University, Loyola University Chicago Stritch School Of Medicine.
What skills is Diane Barnes known for?
Diane Barnes has skills like Regulatory Affairs, Clinical Development, Fda, Clinical Trials, Pharmaceutical Industry, Ind, Regulatory Submissions, Cro, Clinical Research, Oncology, Protocol, Regulatory Requirements.
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