expert insights webinars

Award-winning experts share their detailed and actionable insights to inform the future of pharma, biotech, and medical devices

View the our complimentary webinar offerings below and register for one or more webinars.

Expert Insights webinars, presented by MMS

The Expert Insights webinar series offers free learning opportunities on current trends, high-value topics, and complex initiatives in the evolving pharmaceutical, biotechnology, and medical device industries. Current and archived webinars are available as follows:

 

EU Clinical Trials Regulation: The Clinical Trial Transparency Revolution (June 29)

The EU Clinical Trials Regulation (Regulation No 536/2014) will enter in force in January 2022, changing clinical trial processes in Europe and impacting clinical trial activities worldwide. At the center of this new CT Regulation is the EU Clinical Trials Portal, a single-entry point for Sponsors, Health Authorities, and the public. For the first time, European citizens and the rest of the world will have access to almost all study documents and data. This webinar will explore how the new CT Regulation will impact sponsors, and will take a closer look at changes to clinical trials processes, protocols, Informed Consent for minors, and impact to lay summaries. To prepare for this major step, Sponsors will have to rethink their clinical trial disclosure and transparency policies and supporting processes.

In this Expert Insights webinar, attendees will learn:

  • Key takeaways from the EU Clinical Trials Regulation
  • How the EU CT Regulation will impact Sponsors
  • Tips for Sponsors as they prepare for the changing regulation
  • Insights into how these changes will impact worldwide clinical trials activities
  • Brief review of the impact to talent planning and core competencies

Presenter(s)

Karim Ibazatene, Associate Director, Transparency

Alan Nicolle, Senior Director, EU & SA Operations

Kelly Vaillant, Director, Global Transparency Strategy and Compliance

This webinar is presented in partnership with TrialAssure. 

The Blueprint for Success for Effective and Efficient Clinical Protocols (August 12)

Clinical study protocols are vital to drug development, and when carefully designed, deliver practical clinical care and answer critical research questions.  This balance of science and medicine provides the foundation for advancing the next big idea from the laboratory to the pharmacy. Still, this achievement is dependent on each drug’s ability to demonstrate safety and effectiveness during the phases of a clinical trial. Explore with us as we discuss different protocol writing and study design approaches, ensuring protocols are designed to meet both the patients’ and Sponsor’s needs, and maintaining compliance with the International Council for Harmonisation requirements.  

In this Expert Insights webinar, attendees will understand tactical approaches to protocol development, including:

  • Key differences in clinical study design among phases of development
  • Statistical methods for interpreting analyses
  • New efficiencies in clinical study design strategy
  • Benefits of using the master or subprotocol
  • Benefits of tech-enabled templates

Presenters:

Aaron Burr, Senior Medical Writer, Regulatory and Medical Writing

Tasnim Hoda, Manager, Regulatory and Medical Writing

Hung Lam, Principal Biostatistician, Biometrics

Victoria Murray, Technical Manager, Regulatory and Medical Writing

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Data Management
& Biostatistics

Regulatory
& Medical Writing

Drug Safety
& Pharmacovigilance

Compliance
& Transparency

Data
Sciences


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