Events

Conferences

March 6-8, 2018

FEATURED CONFERENCE

FDAnews - ICH E6 GCP INTERACTIVE WORKSHOPS
RALEIGH, NC

The clinical trials world is going back to school. New ICH E6 (R2) guidelines require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.

You can get all the training you need to meet these challenges with three days of hands-on workshops aimed at helping you understand and comply with new ICH E6 (R2) requirements. Teaming up with Technical Resources International Inc., we’ve created a pair of workshops that meet the needs of everyone along the clinical trials spectrum, from trial sponsors to trial operators and overseers.

These workshops are aimed at every sector of the clinical trials world—drug and biologics makers; trial sponsors, trial sites and CROs; academic medical centers and IRBs—and the individuals who make trials happen:

  • QA/QC managers and staff
  • RA managers and staff
  • Compliance auditors
  • Manufacturing managers
  • Project managers
  • Senior managers
  • Supply chain and logistics managers

To see the full schedule and register, go to: www.fdanews.com/iche6gcp.

April 10-11, 2018

Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers
Cambridge, MA

In two action-packed days, you'll learn what FDA investigators use to evaluate your sites. This interactive workshop will teach you how to develop risk-based CQA processes and compliance readiness.

You'll benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.

Auditing veteran Michelle Sceppa walks you step by step through such details as:
  • A review of how FDA conducts clinical inspections and the top 5 GCP violations
  • How to write GCP audit SOPs — what elements to include
  • Writing a central laboratory audit SOP and why you need this SOP
  • Selecting sites to be audited — creating a master audit plan and how to make sure it is met
  • Audits of a central laboratory — why lab data and testing are a critical component of the clinical study

For details and registration, Click Here

Training Programs

More to come soon

Webinars

February 20, 2018

A WCG Webinar

Addressing Acceptable Recruitment Methods for Sponsors & SitesPatient Engagement Solutions to Expedite Study Recruitment

1:30 AM - 2:30 PM Eastern

In just 60 minutes you’ll learn how to optimize the recruitment of subjects for your clinical trials and comply with GDPR requirements. On Feb. 20, one of the leading authorities on patient recruitment will explain how to bring in more subjects while saving time and money.

You’ll learn:
  • How to develop data to understand why studies are behind schedule and over budget when it comes to patient recruitment
  • How to use proven strategies and tactics to improve your patient recruitment numbers
  • How to foster awareness of the importance of implementing appropriate effort into creating a recruitment plan for a study
  • How to comply with new GDPR requirements
  • How to more effectively recruit patients and comply with new GDPR requirements to avoid putting your new medical product at risk of not being approved.

Meet Your Presenter

Amanda Plucinak, PharmD has been a Program Manager at ThreeWire for almost four years, with a focus on innovative tactics to address recruitment-challenged studies. She also has been transitioning to ThreeWire Quality Assurance Manager, concentrating on ensuring that recruitment tactics are executed within the rubric of regulatory requirements.

Who Will Benefit

This session is appropriate for professionals who conduct clinical trials or who are concerned with the administration of clinical trials, including individuals holding these job titles:

  • Clinical trial sponsor
  • CRO representative
  • IRB member
  • IRB administrators
  • Clinical project manager
  • Clinical research associates
  • Clinical research team member
  • Research coordinator
  • Site manager
  • Site director
  • Principal investigator
REGISTER NOW

February 22, 2018

A WCG Webinar

Recruiting Patients & Time Management Top Tips for Dealing with the Most Critical Resource in Research

1:30 AM - 2:30 PM Eastern

The schedule for your clinical trial is already tight. Getting hung up in the recruitment phase can be detrimental to your trial before it’s even started. But there are ways to avoid that trap, and two patient recruitment experts are here to show you how.

On Feb. 22, 2018, two of the leading authorities on time management in clinical trial recruitment will explain how to save time when recruiting patients. You’ll learn:
  • How to hire the right staffer(s) to dedicate to patient recruitment
  • How to use dedicated staff to managed recruitment efforts and tactics
  • How to execute patient recruitment best practices that eliminate bottlenecks and expedite recruitment timelines

In just 60 minutes, from the comfort of your own office, you’ll learn how to optimize the time you spend on patient recruitment and get your trial off to a strong — and time efficient — start.

Meet Your Presenters

Kari Lotsberg, Manager of Site Services at ThreeWire, has five years of experience ensuring the correct fulfillment, training and development of focused professionals in clinical trial recruitment. She has spent the past three years helping expand the Site Services department at ThreeWire.

Dr. Fabian Sandoval, CEO & Research Director at Emerson Clinical Research Institute, LLC, has more than 20 years of bench-to-bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector.

Who Will Benefit

This session is appropriate for professionals who conduct clinical trials or who are concerned with the administration of clinical trials, including individuals holding these job titles:
  • Clinical trial sponsor
  • IRB member
  • IRB administrator
  • Clinical project manager
  • Clinical research associate
  • Clinical research team member
  • Research coordinator
  • Site manager
  • Site director
  • Principal investigator
REGISTER NOW

February 28, 2018

WCG/CenterWatch

Gene Therapy for Rare and Ultra-rare Diseases -Understanding Scientific and Ethical Considerations

1:30 PM - 2:30 PM Eastern

Many rare or ultra-rare diseases are caused by specific genetic defects, which make them excellent candidates for the development of gene transfer therapies. Do you understand the scientific and ethical considerations of conducting gene therapy research or a clinical trial?

Conducting clinical research to determine the effectiveness of a specific therapy is particularly dicey in this space. You don’t want to do something that could jeopardize the success or legitimacy of your research.

In just 60 minutes, from the comfort of your own office, you will gain a fuller understanding of the scientific and ethical considerations involved in gene therapy for rare diseases. Simply save the date for this FREE webinar on Feb. 28, 2018 — which just so happens to be Rare Disease Day — to hear two of the leading authorities on rare disease safety explain the scientific and ethical issues surrounding gene therapy.

Here’s what you’ll learn during this interactive session:
  • The basic science of gene replacement therapies
  • Examples of therapies in development for rare diseases
  • Specific challenges in the use of gene therapy to treat rare diseases
  • The ethical issues in research involving patients with rare diseases

Take advantage of this free, practical presentation to learn the nuances of gene therapy for rare diseases.

REGISTER NOW

March 01, 2018

CenterWatch/FDANews

Due to unforeseen circumstances this webinar has been postponed until Thursday, March 1, 2018, 11:00 am – 12:30 pm ET

Real World Evidence in Clinical Trials: Are You Prepared for the Practical Effect of RWE’s Explosion?

11:00 AM - 12:30 PM Eastern

The 21st Century Cures Act is very much front and center when it comes to RWE in clinical trials, which places yet another requirement in terms of the types of data needed to support regulatory decision making.

You must have the latest information and guidance on RWE—Now! Simply by attending our 90-minute webinar, you’ll find out what’s really happening with these critical clinical trial issues:
  • The FDA’s use of RWD and RWE to monitor postmarket safety and adverse events.
  • The utilization of RWD to support healthcare coverage decisions.
  • Best practices for integrating RWD and RWE into every phase of clinical trials to produce more statistically valid and reliable, data-based trials.
  • The use of RWD and RWE by medical product developers, including your competitors, to support clinical trial design.
  • The evolving implementation of the 21st Century Cures Act, which places additional focus on data.

After all, data impacts everything you do in clinical trials — from patient recruitment to investigator responsibilities, plus post-trial in postmarket surveillance.

Make sure you’re fully compliant with data requirements for you clinical trials. Don’t wait!

REGISTER NOW

March 20, 2018

A CenterWatch/FDAnews Webinar

Paying Clinical Trial Subjects Deconstructing the Most Important Ethical & Practical Considerations

11:00 AM - 12:30 PM Eastern

If you’re involved in conducting clinical trials in any way, you’re certain about one thing: There is tremendous uncertainty in regard to the appropriate parameters for paying clinical trial subjects. What are appropriate real-world ethical and regulatory considerations that impact payment offers? How are reasonable payment offers to clinical trial participants designed? The research community continues to debate these issues with seemingly no clear-cut answers in sight. You need clarity — not in the distant future — now.

This webinar will systematically review the thorny area of paying subjects in clinical trials — and the particular issues involved in pediatric and geriatric research — to enable you to determine if, when and how to compensate your research subjects. You’ll find out what the regulators think you should be doing — what’s ethical and what’s legal.

In just 90 minutes, from the comfort of your own office, you can take a deep dive into the murky waters of paying subjects in clinical trials and emerge with a fuller understanding of the ethical and practical considerations involved in this critical area of clinical research. Save the date, March 20, 2018, to hear one of the leading authorities on clinical trial subject payment and protection explain the ethical and practical issues.

Here’s what you’ll hear during this interactive session:
  • Reasons to pay research participants, in regard to fairness and the role that payment plays in facilitating recruitment.
  • Ethical and other concerns about offering payment, including the risk of undue influence and the possibility that payment might motivate deception about eligibility.
  • Current practices regarding payment of research participants, such as payment rates and frequency of payment in various types of clinical research.
  • Methods of calculating payment amounts, including distinguishing different reasons for offering payment (such as reimbursement, compensation for time, or recruitment incentive).
  • Understanding the legal, practical and ethical standards for clinical trial subjects.

Meet Your Presenter

Luke Gelinas, PhD., Senior Researcher with Petrie-Flom Center at Harvard Law School is the lead member of a working group dedicated to clarifying regulatory and ethical issues around paying subjects and facilitating investigator proposal and IRB review of payment offers. Gelinas joined the Petrie-Flom Center in 2015 as the first Petrie-Flom Fellow in Research Ethics.

Who Will Benefit

This session is appropriate for professionals who are involved in clinical trials, including individuals holding these job titles:
  • Patient and patient advocacy representative
  • IRB members
  • IRB administrators
  • Clinical project manager
  • Clinical research associate
  • Clinical research team member
  • Biosafety professional
  • Biometrics specialist
  • Data management specialist
  • Medical ethicist
REGISTER NOW

TBD, 2018

WCG

Improving Your Feasibility Selection

1:30 PM - 2:30 PM Eastern

Site selection is essential to your clinical trials, so you must be laser-focused on site feasibility.

Think about it. Site selection is the introduction — a first date — between the site and a sponsor or CRO. And then there’s a determination of whether the relationship is going to move forward. What are the study design and deadline assumptions? Like any relationship, how do you determine if this is the right one for you?

Exactly how do you go about making perhaps the most difficult decision in the clinical trials process when it impacts everything in the trial itself? How much time and analysis should you spend on this critical game-changer?

As a sponsor or CRO, you simply cannot have a flawed feasibility process. You cannot continue to blast out cumbersome, repetitive and lengthy questionnaires with extraneous questions, bombarding a potential site with even more e-mail solicitations.

Stop the madness. Learn how to make your questionnaires more succinct, your data actionable, and your study more appealing to prospective sites. Bottom line: Be more productive. Increase your response rates.

The good news: In just 60 minutes, from the comfort of your own office, you can take a practical, insightful dive into this quagmire and emerge with a fuller understanding of how to determine site feasibility. Don’t spend thousands more dollars on attorneys and consultants. In fact, don’t spend any money at all because this webinar is free. Simply save this date — February 22, 2018 — to hear one of the leading authorities on the site feasibility selection to explain how to:
  • Pre-identify the most likely high-performing sites based on available historical performance data;
  • Provide advice for tightening up feasibility questionnaires to reduce site burdens;
  • Give real-world examples of do’s and don’ts in questionnaire development and how to do it more effectively;
  • Offer insights into response data review and how to handle discrepancies;
  • And much more!
  • As the industry trends toward doing more with less while expanding globally, it is more important than ever to ensure companies nail the feasibility aspect of trial management. As a sponsor or CRO, you can’t afford to waste time and money on underperforming sites or miss projected timelines in this competitive landscape.

Really, don’t you want to make the site feasibility selection process more predictable, less costly, and far, far more productive?

Your presenter, Wes Martz is an Associate Director in ePharmaSolutions’s Clinical Services division, specializing in feasibility and patient recruitment. Martz has helped dozens of clients with protocol and site feasibility, and he can support your organization too.

Take advantage of this free, practical presentation to learn the nuances of site feasibility selection. Sign up now.