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:

 

Preparing for an FDA inspection – what you need to know (Oct. 22)

Date: October 22, 2020; 2:00 pm ET (11:00 am PT)

Abstract:

This Expert Insights webinar will provide an informational overview on the intersection of inspection readiness, quality systems, and regulatory submissions. Aspects of Quality by Design and Quality System Management provide a framework for building robust and compliant dossiers for successful regulatory submissions, as well strategies to reinforce compliance within your program to ease the regulatory inspection process and improve the outcome.  Understanding the regulations is only half the battle, and defining a strategy for continuous compliance will allow for a successful drug or biologics approval. 

During this webinar, MMS will discuss aspects of preparing for inspections and regulatory submissions, including:

  • Providing an introduction to types of inspections including NDA and BLA pre-approval inspections
  • The strategy – a three-pronged approach and best practices to ensure compliance
  • Quality Assurance and Risk Assessment tools to aid in Inspection Readiness
  • Knowing what the inspector knows – Using the compliance program manual as a guide for preparations
  • Value of coordinated planning between QA and Regulatory Affairs including clear responsibilities and timelines

Presenters:

Jennifer Perrin, Senior Quality and Compliance Specialist (Ohio, USA)

Simon Powell, Senior Quality and Compliance Specialist (United Kingdom)

 

Automating the Review of Aggregate Safety Data – An In-Depth Look (Oct. 29)

Date: October 29, 2020; 2:00 pm ET (11:00 am PT)

Abstract:
In this Expert Insights webinar, drug safety and data science professionals will discuss the methods and tools within the  pharmacovigilance arena to more efficiently combine data for the purpose of monitoring and signal detection. There is the need for data reviews in real-time and flexibility to visualize this data at both the program and patient level.

The automated review of aggregate data can be implemented to reduce errors and cycle time compared to traditional line listings and static data reviews. Purpose-built tools, like Datacise, which provide visual analytics allowing safety teams to quickly identify potential ADRs and focus on safety signals, will be discussed. Additionally, experts will present an innovative method that saves time and reduces risk by flagging clinically significant events within a subpopulation and across multiple data domains.

Attendees will learn:

  • Strategies in the automated review of clinical trial level and aggregate safety data
  • Strategies to reduce risk and more efficiently assess safety within your clinical development program
  • How purpose-built technologies can reduce errors and reduce review cycle times

Presenters:
Margaryta Mare, MD, Medical Director, Drug Safety & Pharmacovigilance
Aditya Gadiko, MS, Senior Data Scientist
Seun Matthew, MD, MBA, Senior Medical Reviewer

Tips and tools for writing effective plain language summaries (Nov. 18)

Date: November 18, 2020; 2:00 pm ET (11:00 am PT)

Abstract:

The EU Clinical Trials Regulation 536/2014 (Article 37) requires that sponsors provide summary results of clinical trials conducted in the European Union in a format understandable to laypersons, at a 6th- to 8th-grade reading level. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians, and it requires medical communicators to develop and hone a unique skillset to write lay summaries effectively and efficiently. This webinar provides an overview of plain language summaries, highlights the 10 key elements comprising these summaries, describes the core competencies for writing these documents, and discusses the challenges medical communicators face in writing these summaries. Learn tips and tools for writing a non-promotional and succinct document that can be used and easily understood by the target audience.

Attendees will understand:

  • Key data elements required in a plain language summary
  • The target audience for a plain language summary
  • Tips and tools to write summaries that can be easily understood by patients and other members of the general public

Presenters:

Kasim McLain, Manager of Transparency

Michelle Reed, PhD, Medical Writer

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Data Management
& Biostatistics

Regulatory
& Medical Writing

Drug Safety
& Pharmacovigilance

Compliance
& Transparency

Data
Sciences

 

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