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The Rundown: ExL’s Blog

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Engage With an MHRA Inspector at the European TMF Summit

As you know, the MHRA has been the leading driver when it comes to the trial master file. They have not only been at the forefront of advancing regulations but communicating it as well. To assist in communicating TMF regulations, ExL Events is excited to welcome Andrew Fisher, Senior GCP Inspection from the MHRA, to the 7th European Trial Master File Summit.

Topics discussed during the MHRA presentation include:

Learn what is required to be certified and get updates and clarifications
Discuss when and for which digitised documents certified copy is expected
Discuss pain points and challenges through case examples
Study lessons learned about…

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Patient Experience Gathers Pioneers From Pharma and Healthcare Industries

The 2nd Patient Experience Forum, taking place on June 4–5 in Jersey City, is the only high-level conference dedicated to bringing together healthcare and pharmaceutical professionals who want to improve the patient journey. Download the brochure to see all of the speakers and session descriptions.

Including patient experience as an essential part of a company’s strategy is relatively new and is still not a common practice. The forum’s speaking faculty gathers leaders from every aspect of the entire medical industry including pharma, medical devices, biotech, healthcare, associations, service providers, agencies, and more. They are pioneers equipped to give you a better understanding of strategies…

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JUST ANNOUNCED: TMF Institute — Courses for the TMF Professional

ExL Events is pleased to announce the inaugural TMF Institute — a landmark education and professional growth opportunity for the life science industry. This event will take place on July 11–12, 2018, at the Colonnade Hotel in Boston.

A Trial Master File (TMF) is a collection of all essential documents and data related to a clinical trial. The TMF demonstrates that the trial sponsor — a pharmaceutical, biotech, or medical device company has fulfilled its obligations for a clinical trial. Electronic TMFs (eTMFs) are expanding the utility of a TMF from being a repository to functioning as…

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Q&A Session With Michael Hellerstein From GeoVax

Before taking the podium at our upcoming 2nd eRegulatory Submissions Summit, GeoVax’s Michael Hellerstein sat down with ExL to discuss his experience with implementing electronic submissions at a small company. Take a look below:

 
We’re excited to welcome you as a speaker at ExL’s 2nd eRegulatory Submissions Summit! What do you hope attendees will take away from your presentation on The Juggling Act of Implementing Electronic Submissions at a Small Company?
I am grateful for the opportunity to speak at the 2nd eRegulatory Submissions Summit, and I predict that it will be a very interesting and rewarding meeting! Since…

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JUST ANNOUNCED: The 14th Pharmaceutical Meeting Professionals Summit

The 14th Pharmaceutical Meeting Professionals Summit will be held on November 13–14, 2018, at the Hyatt Regency New Brunswick in New Brunswick, NJ, we are proud to announce today. This intimate Summit attracts an elite audience of senior-level meeting planners, working in the pharmaceutical, biotechnology, and medical device industries, and acts as their annual gathering to learn, engage, and network.

With close to 70% of the 2017 audience representing meeting planners and 60% having 10+ years of experience in the events industry, the Pharma Meeting Pros Summit is the ideal forum to learn from and meet with industry veterans to…

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The Latest Patient Experience News!

As an industry professional, you’ve likely heard a lot about the latest patient experience initiatives in the news; but we wanted to make sure you had a chance to check out the following articles!

Students in the School of Architecture’s Healthcare Design Studio create a talking exam-room wall to help ease patient stress
Overcoming the Top Patient-Reported Outcomes Measures Challenges
Mayo Clinic’s new social media campaign highlights the patient experience in patients’ own voices
Patient advocate: Learning to navigate the healthcare system akin to mastering a new…

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European Clinical Trials Inspection Readiness Summit Early Bird Ends Soon!

This is the last week to receive discounted pricing for the 4th European Clinical Trials Inspection Readiness Summit, taking place on 21–22 May 2018 at the Radisson Blu Portman Hotel in London. Register by Friday, 13 April and save £150 off standing rates. Be sure to mention Priority Code C1018BLOG when signing up.
Featured Sessions
EXPLORE THE EFFECTS NEW DATA INTEGRITY GUIDELINES AND REQUIREMENTS HAVE ON INSPECTION READINESS
Kath Williams, KEW QUALITY CONSULTING LTD., FORMER MHRA GCP

HOW TO SURVIVE THREE FDA GCP SPONSOR INSPECTIONS IN EIGHT MONTHS
Winnie Søjborg Sussoh, International Trial Manager Specialist, Inspection Readiness, NOVO NORDISK

PV — GCP CLINICAL TRIAL…

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Final Week — Expiring Discount for the 2018 Off-Label Regulatory Compliance Congress!

There’s still time to reserve your seat and get discounted pricing for the 2018 Off-Label Regulatory Compliance Congress on May 21–22 in Herndon, VA. We want to ensure that you have the BEST rate possible — don’t miss out; this exclusive offer expires Friday, April 6!

Sponsors

Given the public health issues at stake and the public interest involved, our agenda details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical,…

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Check Out the Latest Patient Experience News

As an industry professional, you’ve likely heard a lot about the latest patient experience initiatives in the news; but we wanted to make sure you had a chance to check out the following articles!

Students in the School of Architecture’s Healthcare Design Studio create a talking exam-room wall to help ease patient stress
Overcoming the Top Patient-Reported Outcomes Measures Challenges
Mayo Clinic’s new social media campaign highlights the patient experience in patients’ own voices
Patient advocate: Learning to navigate the healthcare system akin to mastering a new…

READ MORE


Learn From Three MHRA Investigators at the European Clinical Trials Inspection Readiness Summit

Unfortunately, it’s often employees that know the most about frontline operations that have the least experience with inspections and therefore are more likely to make a mistake. That’s why training for an inspection with all management is as important as having an inspection process in place.

Regulatory Investigators are competent, highly educated, trained, motivated, and experienced in flushing out problems and violations. Don’t miss the opportunity to gather critical intelligence and guidance straight from the source at ExL Events’ 4th European Clinical Trials Inspection Readiness Summit, 21–22 May 2018 in London.

This year, we’re excited to bring you three…

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