- Time:
- 3:00pm-4:00pm
- Description:
- Overview:
DTC involves various platforms to convey a message, social media, broadcast media, print media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.
FDA applies principles of cognitive psychology to determine what and how a firm communicates consciously and unconsciously. Firm's that do not understand FDA's regulatory approach to DTC can be costly if you trip one of FDA's legal snares for labeling. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for picking by the FDA.
Why should you Attend: You will learn how to navigate FDA's interpretations and expectations about a firm's DTC marketing practices. Applying a various guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to determine what your message really conveys, whether you meant to or not.
This webinar will provide insight on how to manage your marketing activity when you use DTC advertising and gauge the regulatory risks you face. Attendees will see how a firm's regulatory profile requires cooperation among corporate divisions, such as marketing, regulatory affairs, legal counsel, manufacturing and finance departments. Typically, these divisions work together like oil and water. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. And above all, attendees will also begin to apply the boundaries the FDA uses now and understand how easy it is to promote yourself into a corner.
Areas Covered in the Session:
FDA's approach to DTC advertising and promotion principles
FDA guidance and use of cognitive psychology
Types of violation for illegal DTC advertising practices
Roll of sales and marketing departments
Executives' legal liability
Who Will Benefit:
Regulatory managers
Sales and marketing executives
Owners and managers of new firms
Own label distributors
International trade managers
Product specification developers
Speaker Profile
Casper Uldriks , through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements.
- Time:
- 8:00pm-8:40pm
- Description:
- Steps Your Business Can Take to Mitigate the Risks and Ensure a Smooth Transition to The Cloud
This webinar is for executives who are serious about cloud computing, but are unsure of how to securely and efficiently make the transition.
We've done the reseach for you.
When researching cloud options, it's important to understand the risks, bottlenecks, and productivity traps of moving to a cloud computing provider.
During this webinar, you'll learn:
1.The Signs It’s Time To Migrate To The Cloud
2.Steps To Managing Cloud Expectations
3.How to Identify & Mitigate the Cloud Risks
4.How to Ensure a Smooth Transition To The Cloud
(If you're a cloud computing beginner, you may want to start with our 'Cloud Computing 101' webinar)
- Time:
- 11:00pm-12:00am
- Description:
- Learn new skills to master the various challenges associated with living with a chronic medical condition. Learn how to take charge of your healthcare and self-care. Discover new ways to give your life meaning and purpose, and explore how to best adapt to changes and losses.
This webinar series provides the road map that will guide you in how to increase wellbeing despite health challenges. By engaging in the mindfulness-based practices presented in these webinars, which were developed out of new advances in psychology, you will learn that the power to be the master of your condition and your life is in your own hands.
Each chapter focuses on a tool to cultivate wellbeing and ends with helpful hints on medical self-efficacy.
This educational webinar series will inform you of evidence-based tools developed from recent advances in psychology. To increase mastery wellbeing, self-care & your ability to work collaboratively & proactively with yon partnership with your doctors.
- Description:
- This free training is for you if:
~You’re waking up frustrated every morning and hating your job.
~You’re longing for more meaning and purpose in life and to connect with what you’re truly passionate about.
~You feel you were “made” for something but you’re just not sure what that is.
~You want to have more joy, meaning, fulfillment and impact in life.
~You find yourself living for the weekends and vacation days.
~You’re feeling unfulfilled, drained and a chronic sense of dissatisfaction.
I will be sharing:
~What life purpose is and why it’s important to you and others.
~The benefits of living in alignment with your life purpose.
~What stops people from even getting started on their path to purpose and what to do about it.
~3 essential Keys to understanding and living your purpose.
~A simple but powerful process that will help you to clearly identify what you want in life.
So if you don’t even know what your life purpose is, have doubts and fears about your ability to make a change, or think it’s too late for you, I’ll show you how to love Monday mornings--and your life-- by doing what you are truly meant to do.
- Time:
- 12:30am-1:30am
- Description:
- After the big computers came the smaller laptops, further smaller arrived the mobile phones & tablets; the next evolution wave was the internet; post-internet, the world witnessed AR and VR. The buzz of Virtual and Augmented Reality today is very vast. Not only are they well-established, their reach continues to grow. Along with this latest wave of evolution, lies the marvelous concept of Mixed Reality.
“Mixed Reality is THE Next Reality! While Microsoft’s betting on ‘mixed reality’, the Outgrowth of Mixed Reality has the potential to Transform Communication, Collaboration and the Future of the Workplace”- IndustryARC.
Several startups are taking interest in the Mixed Reality Market with the existing proofs of how saturate a medium this is, for marketers. “Bored with the virtual reality” could be the common phrase soon with rising number of players and investors showing keen interest in R&D of Mixed Reality Market. Identifying obstacles and solutions is the smartest avenue competitors are opting for in order to bring mixed reality into existence for the best.
Mixed reality has the potential to allow a global workforce of remote teams to work together and tackle an organization’s business challenges. – External Source
According to IndustryARC survey, a combination of virtual, augmented and mixed reality Gaming can be one of the biggest game changers in the coming future. Let’s consider the exquisite Pokémon Go location based augmented reality mobile game developed by John Hanke, a few weeks ago. Who knew (I’m sure he himself didn’t) that the invention would create such dazzling buzz worldwide for android and iPhone users? None! So why is it so? Because this revolution is far more immersive than you can think or imagine!
- Time:
- 3:00pm-4:00pm
- Description:
- Overview:
The seminar will cover the true aspects of the financial aid process that will allow a family to properly pursue financial aid and therefore retain more good aid for college. It will cover the common mistakes people will make in the process and other valuable information that will make the family an informed consumer.
Why should you Attend: If you need to file for financial aid, this Seminar is a must! It will offer advice and tips that will benefit you in many ways. You will learn the true aspects of the financial aid process that will allow a family to properly pursue financial aid therefore retain more good aid for college. Learn of the common mistakes people will make in the process and other valuable information that will make you an informed consumer.
Areas Covered in the Session:
How colleges determine need based financial aid eligibility.
The differences in the 3 financial aid forms.
How to lower your EFCs therefor more financial aid.
How to improve an initial financial aid offer.
Why a student should apply to a minimum of six different schools.
Why early decision is not recommended.
What deadline(s) one should go by for applying for financial aid.
How to avoid financial aid awards that shrink every year.
Why the CSS Profile will not benefit the student in receiving aid.
Financial assets & how they affect financial aid.
Why private scholarships may not be worth it.
What to know about the college aid bait & switch game.
Who Will Benefit:
College bound students
Parents of college bound students
High School Guidance Counselors
CPAs
Tax Accountants
Leaders of Community Education Programs
Corporations & companies who have education benefits for their employees
Speaker Profile
Ronald Ramsdell Founder and President of College Aid Consulting Services is thoroughly trained in the Federal Methodology, Institutional Methodology, Consensus Methodology and all the rules and regulations governing Financial Aid. His 26 years of experience has intensified his advocacy for improvements in the identification of Financial Aid opportunities and matching the right programs with family’s needs. Over the years, Mr. Ramsdell has shared his expertise in assisting thousands of families in achieving their goal of post-secondary education while reducing their out-of-pocket expenses.
- Time:
- 2:00pm-3:00pm
- Description:
- This teleseminar is designed for Moms whose child has left home. This is a time of great change! this Teleseminar will provide support and ideas about how you can use this unique transition to thrive in your personal growth.
- Time:
- 3:00pm-4:00pm
- Description:
- Overview:
Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure.
Confidential information from the manufacturer must be protected. However, at the same time the license-holder must receive all the information it needs in order to takeresponsibility for the quality of a medicinal product. A drug master file comprises two parts: the Applicant’s Part (Open Part), which contains all the information that the license-holder needs to assess the quality and submit a license or amendment application; and the Restricted Part (Closed Part), which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities. It should be noted that DMF's may only be submitted in connection with a licensing or amendment application or as part of a periodical review procedure. The DMF should be submitted in the format described in the Common Technical Document (CTD) Part 3.2.S. This Webinar will focus on the European Community procedure where information can be provided to the authorities and the applicant, where the active substance manufacturer is not the applicant for a product marketing authorization, with a view to protecting valuable manufacturing know-how. This session will use the words "medicinal products" and these cover both products for use in humans and veterinary products. This Webinar will focus on the European, not FDA’s DMF or Master File.
Areas Covered in the Session:
Examine the background and history with the EDMF
Learn step-by-step how to construct and submit the EDMF (and this is not FDA's DMF)
DMF’s today are mostly prepared following the rules of Common Technical Documentation (CTD)
Understand that this is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant
Expectations for Applicant's part and ASM Restricted Part of the EDMF
When to submit an EDMF? Who can submit an EDMF?
Where and how to submit an EDMF? Are EDMFs to be approved by the authorities, e.g., the Competent Authorities in Europe?
Recordkeeping requirements and your responsibilities
Combination medical device and drug manufacturers will also benefit if you incorporate a medicinal product and how the Competent Authority will assess your Master File
Who will benefit:
This webinar will provide valuable assistance and guidance to manufacturers who must prepare and submit the Drug Master File (Active Substance Master File) to European Competent Authorities. Employees who will benefit include:
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the EDMF process and expectations
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations
Consultants
Speaker Profile
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
- Time:
- 4:00pm-5:00pm
- Description:
- "Automate your Contract Management process With SharePoint & Office 365"
- Time:
- 7:00pm-7:30pm
- Description:
- Better access is better business. AccessCheck is your source for accessibility solutions and information. We help businesses become more disability friendly. Join us for one or all of our free 30 minute webinars. Registration required.
- Time:
- 7:00pm-8:00pm
- Description:
- Making decisions can be challenging, especially when the problem is complex, ill-defined and involves multiple stakeholders. If you are not facing these sorts of decisions already, you almost certainly will as your career advances. Most of us believe that we make the majority of our decisions rationally and deliberately. But we do not. Most of our decisions are made intuitively and those that are not still involve varying degrees of subjectivity.
Taking place on 8 December 2-3pm AEDT, this free webinar will teach you how to recognise and deal with some common decision making errors. You will be able to boost your career in 2017 by improving the quality of your decisions and achieving commitment from others to them.
- Description:
- Hi, Divine Ones –
My upcoming program Tap into Your Divine Money getting ready to start. We’re going to cover how you connect with, feel about and use money. We’ll have all of the yummy tapping exercises, powerful meditations, and how to’s that you love getting with your trainings.
In just four weeks, you'll create a new relationship with the energy of money so that abundance can start to flow in ... just in time for 2017!
We start next week, so don’t wait! I’d love to see you there.