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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 It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and...

Continued Process Verification (CPV), the 3rd Stage of the FDA process validation guidelines, represents the Ship of Theseus in bioprocessing: The bioprocess is validated and on the market, but it inevitably is subject to changes in supplies, raw...

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...

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...

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...

Are you awake and alert? – It’s hard to stay awake and alert to what’s important in the world of sterile pharmaceutical manufacturing. Challenging. A big world. A lot is happening. But the 2019 ISPE Aseptic Conference captures what’s important:

Thomas Zimmer, PhD VP, European Operations ISPE Staff ISPE is pleased to announce that the Academie Nationale de Pharmacie has invited ISPE’s VP of European...

We have so much to celebrate for all the Women in Pharma accomplishments in 2018!

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...

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...

Charlotte Enghave Fruergaard, PhD Partner, Compliance Consulting NNE Charlotte Enghave Fruergaard joined ISPE in 1995. A member of the ISPE Nordic...

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...

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...

2018 ISPE Biopharmaceutical Manufacturing Conference on 10-12 December in Huntington Beach, California, provided information about the future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into...

2018 ISPE Europe Aseptic Conference Recap More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austrian Hungarian Monarchy Capital, Vienna. Austria is a...

Many reasons to celebrate In the last week of November, the inaugural ISPE Europe Aseptic Conference took place in Vienna, Austria. With its emphasis on innovation in aseptic processing with focus on new regulation and pharma 4.0, this conference drew...

As the end of the year approaches, many people are commenting how quickly this year has passed. This time of the year is when we typically reflect on our accomplishments and start strategizing next year’s goals. Taking proactive actions for our own...

Student Poster Competition Undergraduate Winner The 2018 ISPE Annual Meeting & Expo completely exceeded my expectations in all aspects from the: Lessons I couldn’t have learned anywhere else, What-I-thought-was-impossible networks I...