SOURCE: Xtalks

Xtalks Webinars

February 04, 2016 07:00 ET

Regulatory Readiness for Clinical Trial Supplies, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - February 04, 2016) - This webinar will help clinical supply teams clarify and develop an approach to clinical supply chain rules, including supply specific EU rules and FDA pre-approval inspections for clinical supply operations. The live broadcast takes place on Tuesday, February 23, 2016 at 11am EST (4pm GMT).

Clinical trial supply professionals frequently navigate the tangled web of import/export regulations that govern global supply chains. However, in 2016 there are 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.

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

Join experts from Fisher Clinical Services for an information session that will include a Q&A session with the audience. Accredited by the boards of pharmacy association 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.

To register for this complimentary event visit: Regulatory Readiness for Clinical Trial Supplies

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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