PharmaLexpert Office Hours
Your Success is our Purpose at PharmaLex. We are driven by a resolute commitment to propel the life sciences industry forward. Through PharmaLexpert Office Hours, we aim to contribute to your success by providing unparalleled expertise and insights, ultimately fostering advancements in the industry.
PharmaLexpert Office Hours is your gateway to expert guidance in navigating the intricate landscape of life sciences product development PharmaLexpert Office Hours provides you with a unique opportunity to connect virtually with our seasoned experts in:
- R&D Product Development
- Quality Management & Compliance
- Regulatory Affairs & CMC
- Statistics & Data Science
- Pharmacovigilance (Patient Safety)
- Medical Devices/IVDs
Select your interest area
As the leading provider of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our top priority – but it doesn’t stop there.
We strive to ensure you feel confident that your needs are being met, your reputation is protected, and your business objectives are on track.
Connect with Experts
Meet with one or more of our experts across the product development life cycle to get answers to your questions. Our team can address topics related to Product Development, Regulatory Affairs, Pharmacovigilance, Quality Management & Compliance, Statistics and Data Science and any combination thereof.
Get Answers
Schedule a quick meeting with one of our many experts who specialize on solutions across the product development and commercialization life cycle and get answers to help move your project forward.
Regulatory Affairs & CMC
Renata Kover
Senior level CMC Regulatory Affairs strategist with expertise in multiple regulatory pathways, across many product / program types, and with an eye toward end-to-end lifecycle management. Excellent written and oral communicator, with team-oriented focus and creative regulatory thinking.
Cary Smithson
Senior Director, Regulatory / R&D Digital Transformation with 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, simplify information management and the use of technology.
Rob Jones
Rob Jones leads our TMF Professional Services group which includes over 50 industry experts, services include solutions such as TMF Study Resources and Expert Consulting.
Anna Perelka
Director Regulatory Affairs with +10 years of experience in EU & US advising clients on strategic aspects related to initial MAA/BLA/NDA and ANDA submissions and life-cycle activities.
Quality Management and Compliance
Patrick Nieuwenhuizen
Patrick has worked in various Managerial Quality roles in Global Pharmaceutical Companies with over 25 years of experience, covering several platforms including Biologics, Sterile Lyophilisation & Fill Finish, Vaccines and oral Dose. Patrick is a qualified Lead Auditor and SME in Quality Control, Sterility Assurance, New Facility Design / Upgrade, Risk Management
Regina Dawkins
Mirian J. Alvarez Berrios
Louise Ui Fhatharta
Quality Management & Compliance
Over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device (including Combination Products). Involved in site and laboratory expansion projects from design through to method transfer and operational readiness. Supported site in a capacity of Quality, Sterility Assurance and Microbiology Lead oversight during projects. Through industry experience strong analytical and problem-solving skills have been attained and highly developed strong leadership skills. Successful experience with several competent authority inspections including but not limited to FDA, HPRA, AMVISA and DEKRA inspections
Data Strategy & Quantitative Sciences
Lin Li
A statistician and computational biologist by training and twelve years of experience in statistical methodology development and analysis in the fields of pharmaceutical biostatistics, statistical genomics, biomarker analytics, precision medicine, and machine learning.
R&D Product Development
Mark Lane
Over 30 years of experience at some of the world's leading institutions and companies. His drug development experience includes both biologics and small molecules across multiple therapy areas. He has progressed several assets through development from preclinical through Phase 3.
Pharmacovigilance
Stephen Sun
A physician who will provide strategic and operational guidance and leadership to the US Pharmacovigilance team. Brings some years of experience from working as a Sponsor (clinical, med affairs, PV/RM leads), a regulator (US risk management, controlled substances), and a vendor (global operations, clinical and post-approval RM, benefit-risk).
Med Tech
John Lockwood
John Lockwood joined is Sr. Director, Head of Medical Devices/IVDs, Americas. John has a strong background in both Quality Assurance and Regulatory Affairs. He most recently ran an independent consulting company that provided both quality and regulatory services for medical devices and pharmaceuticals.
Disclaimer:
Information provided during PharmaLexpert Office Hours is provided for marketing purposes and represents the opinion of the individual subject matter expert and does not represent the opinions of PharmaLex GmbH or its parent Cencora, Inc. PharmaLex and Cencora strongly encourage participants to review available information related to the topics discussed during PharmaLexpert Office Hours and to rely on their own experience and expertise in making decisions related thereto. By clicking to schedule PharmaLexpert Office Hours, user acknowledges that PharmaLex and Cencora provide no warranties with regard to the content discussed during PharmaLexpert Officer Hours and user disclaims any and all potential claims related thereto.