iSpeak Blog
Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Sunday, 17 March | 1300–1800 Monday, 18 March | 0730–1830 Tuesday, 19 March | 0700–1700 Exhibit Hall Hours Monday, 18 March | 1015–1815 Tuesday, 19 March |...
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North Bethesda, Maryland is a popular travel spot for the ample shopping destinations, fine dining options, rich history, and proximity to our nation’s capital, Washington, D.C. The state of Maryland itself holds many hidden gems for outdoor activities,...
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Two of the contributors for the ISPE Baseline Guide: Sterile Product Manufacturing Facilities, discuss the modern technologies and break down of regulatory guidelines that will greatly assist pharmaceutical professionals and their facility...
iSpeak Blog
The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the...
iSpeak Blog
It's been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and...
iSpeak Blog
We provide a complete toolkit for you to easily host a successful event The Women in Pharma® toolkit is ready to help you host an event for your ISPE affiliate or chapter. Incredible events with thought-provoking topics have already been hosted across...
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Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or...
iSpeak Blog
Conference Essentials Conference AgendaTravel Tips Registration and Information Hours Thursday, 7 February | 0700–1800 Friday, 8 February | 0700–1430 Exhibit Hall Hours Thursday, 7 February | 1015–1815 Friday, 8 February | 1030–1430 2019 ISPE...
iSpeak Blog
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10-11 December 2018 in Huntington Beach, California, featured a broad emphasis on both new scientific developments and the perspective of regulators in assessing those developments. The interaction of the pharma industry and regulators is...
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FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
iSpeak Blog
Clinical trials becoming more complex and protocols are more demanding than ever. Long-term participation/commitment and frequent travel to investigator sites is a critical element for patient to decide if they want/can participate in a clinical...
iSpeak Blog
As we approach the end of this year, we want to thank each of you—members, volunteers, leaders, and staff. We appreciate your great work, commitment, and dedication, which have been integral to ISPE’s progress and growth. In 2018, we supported Women in...