Regulatory Readiness for Clinical Trial Supplies

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • February 23, 2016

Clinical trial supply professionals frequently navigate the tangled web of import/export regulations that govern global supply chains. However, in 2016 they have two new regulatory imperatives with the start of clinical supply specific rules in the European Union and a new inspection strategy from the U.S. Food and Drug Administration.

Clinical trials – Regulation EU No. 536/2014 goes into effect no earlier than 28 May 2016. Once implemented, this regulation will replace the Clinical Trials Directive of 2001. Most important to clinical supplies is a section of the new rule that requires expiry labeling on immediate packaging.

Though aware of this rule, many clinical supply teams remain confused about it, especially given lingering uncertainty about implementation. Meanwhile, FDA’s refreshed focus on inspections raises additional worries. While “for cause” inspections are rare in clinical supplies, this new emphasis from FDA raises legitimate concerns about compliance.

In this interactive webinar, Fisher Clinical Services will draw from 25 years experience meeting supply chain rules across the globe. Key to the company’s latest strategy is becoming a verified-accredited wholesale distributor through the U.S. National Association of Boards of Pharmacy.

Accredited since 2012, Fisher Clinical Services completes rigorous compliance reviews, including inspections of operating policies and procedures, licensure verification, surveys of facilities and operations, background checks, and screening through the association clearinghouse.

Learning Objectives:

  • Develop an approach to the supply chain rules
  • Use national pharmacy association standards to improve compliance in clinical supply facilities
  • Receive unique clinical supply perspective into your most urgent and high impact regulatory concerns

Fisher Clinical Services looks forward to the audiences active participation in this webinar. Please come prepared with any concerns about the supply specific EU rules and FDA compliance issues for clinical supply operations.

Speakers

Harry Berlanga, Lead Qualified Person (QP), Fisher Clinical Services

With a BSc (Hons) in Biomedical Sciences and Post Graduate Diploma in Pharmaceutical Studies at the University of Brighton, Harry works as a Qualified Person (QP) and is a chartered Biologist and member of the Society of Biology. Harry currently holds the role of Lead QP at the Fisher Clinical Services Horsham, UK, site with the added responsibility of managing the entire QP team. He has been named on the Horsham License as a QP for 4 years.

Prior to joining Fisher Clinical Services, Harry spent 10 years at GlaxoSmithKline in the UK. He started in the stability testing laboratories and progressed into various operational quality roles within orals and sterile manufacture. He also managed the Environmental Monitoring team with QC Microbiology and accepted the role of QC Manager. Harry gained hands-on steriles production experience when he completed a steriles value stream secondment as Process Microbiologist. When he’s not working and managing, Harry enjoys spending his downtime with his wife and two boys.

Maria Matos, DEA and Licenses Manager, Fisher Clinical Services

With over 20 years of Pharmaceutical industry experience, Maria Matos is the DEA and Licenses Manager, supervising DEA Activities for Fisher Clinical Services in Allentown, PA and Mount Prospect, IL. Prior to this position, Maria served as a Validation Technical Writer with Fisher Clinical Services. Other roles within the industry include Quality Services Manager, Applications Technology Manager, ERP Core Team Member, Senior Data and Project Manager, and Validation Consultant.

Maria built upon her educational background in Computer Science and Information Technology with professional certifications such as a Six Sigma Green Belt, PPI Facilitator, and PPI Process Champion. Maria proudly celebrated her sixth anniversary with Fisher Clinical Services in November 2015. She loves reading, bike riding, hiking and “trying out new restaurants with my wonderful husband.”

Asiya Imam, Director of Quality Assurance, Fisher Clinical Services

Continuing a 25-year career in Pharmaceutical R&D, Asiya joined Fisher Clinical Services in 2013 and serves as Director of Quality Assurance in the Mount Prospect, IL, facility. After completing a PhD in Genetic Engineering in 1998, she conducted clinical research at the Memorial Sloan Kettering Cancer Center then moved into industry, supporting quality management within Pharmaceutical companies such as Baxter Healthcare as well as biotech instrument firms.
Especially relevant to webinar attendees is Asiya’s first-hand experience working with regulators. She has over 15 years of experience in non-clinical, clinical and research environments, with five years of hands on experience in FDA regulated biotherapeutics, including recombinant DNA vaccines, viral vaccines and autologous cells. On a side note – since our webinar takes place so soon after Valentine’s Day – Asiya has significant research experience in sex specific mechanisms of cardiac hypertrophy.

Who Should Attend?

Clinical teams, plus professionals in clinical supplies, logistics and outsourcing, including those working within:

  • Clinical Supply Team
  • Comparator Sourcing Team
  • Clinical Management
  • Procurement Team
  • Clinical Trial Team
  • Supply Chain Department (CRO)
  • Clinical Development
  • Investigator Dites
  • Clinical Operations
  • Clinical Supplies & Investigational Supplies
  • Clinical Packaging
  • Clinical Labeling
  • Clinical Quality Assurance/Quality Control
  • Regulatory Affairs
  • Clinical Project Management

Xtalks Partners

Fisher Clinical Services

Fisher Clinical Services is one of the world’s leading providers of clinical supply chain services.

With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including, clinical supply optimization, comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than twenty years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.

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