Leader of Tomorrow

Topic: Announcements: Please post announcements that you have here! 

1.  Announcements: Please post announcements that you have here!

DIA Staff
Posted 03-15-2018 12:16 PM
Announcements: Please post announcements that you have here! Find a neat event? Hear about a great opportunity? Please share them in this thread!

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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
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2.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 03-16-2018 01:26 PM
Edited by Katherine Krauland 03-16-2018 01:26 PM

Webinar: EudraVigilance and Signal Management Updates from EMA!

Mar 22, 2018 from 11:00 AM to 12:00 PM (ET) 

Register through the link: https://goo.gl/kFo1bf

Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with

Sciformix


On November 22, 2017, EMA went live with a new and improved EudraVigilance database which was accompanied by updates to GVP Module VI (ICSR and Safety Reporting) and Module IX (Safety Signal Management). While the attempt to harmonize and standardize safety processes is welcomed, some functionality is not working as expected and there have been some unintended consequences of the changes which have led to an increased workload for many MAHs.

EMA has provided updates and fixes to help resolve the issues and a major upgrade is scheduled in February. Around the same time, the EudraVigilance Data Analysis System (EVDAS) pilot will be complete and fully implemented, so this is a good time to examine all aspects of this new update.


Continuing Education Credits are not available for this event.

Featured topics

  • EudraVigilance latest updates: what's new and what to do next
  • EVDAS updates: it's use and implications on signal management activities
  • Industry perspective: how a leading pharma company is preparing for this change

Who should attend?

Professionals who work in the area of:
  • Pharmacovigilance and Risk Management professionals, including members of,
    • Pharmacovigilance operations
    • ICSR Submission teams
    • Signal Management and safety surveillance teams
  • Regulatory Affairs
  • Chief Medical Officers
  • Heads of Clinical Operations

Learning objectives

At the conclusion of this webinar, participants should be able to:


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
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3.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 03-16-2018 01:26 PM

Webinar: CHMP Meetings: How to Prep for, Manage, and Excel at These EU Regulatory Meeting

Mar 27, 2018 from 12:00 PM to 1:00 PM (ET)

Register through the link: https://goo.gl/L2o5NN

Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with

Sciformix


Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization. This presentation will walk you through how to prepare for, and manage CHMP meetings to achieve a positive recommendation for your product.


Continuing Education Credits are not available for this event.

Featured topics

  • Prepare for and manage CHMP meetings to achieve a positive recommendation for your product
  • Overcome CHMP objections within a limited timeframe
  • Ensure voting participants retain information up until the vote

Who should attend?

Professionals who work in the area of:
  • US regulatory
  • EU regulatory
  • Clinical Development

Learning objectives

At the conclusion of this webinar, participants should be able to:
  • Define the EMA review timeline
  • Evaluate how to prepare for the four different types of CHMP meetings you may face (Expert Group meeting, Scientific Advisory Group (SAG) meeting, Oral Explanation, and PRAC meeting)
  • Assess technology and support needed to successfully manage Q&A in the meetings
 

Location

Online Instructions:
Url: http://engage.diaglobal.org/SPW-3D-Communications-CHMP-Meetings.html?_ga=2.195188590.395181042.1521122933-620165103.1521122933 
Login: Please register for the event through the below link and you will receive the details on how to access and watch the webinar!

 



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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
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4.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 03-16-2018 01:26 PM

Event: Life Sciences and Career Night for Emerging Professionals at Rutgers University

Apr 23, 2018 from 5:45 PM to 8:30 PM (ET)

Register through the link: DIA Life Sciences Career Night for Emerging Professionals


Please join us for an evening of career development stories, tips for finding and succeeding in your own career path, and networking with colleagues and leaders passionate about engaging in current healthcare conversations.
We are hosting this evening to provide you with a network and resources to explore the various opportunities open to you, across patient advocacy, regulatory, research and development, market access, medical affairs, and more. This event is open to all Graduate Students and Emerging Professionals pursuing careers in healthcare and life sciences.

Please register through the link provided, space is limited.

DIA Life Sciences Career Night for Emerging Professionals


Event Details
Monday, April 23 | 5:45–8:30PM ET

Rutgers University Busch Campus
Busch Student Center Multipurpose Room
604 Bartholomew Rd
Piscataway Township, NJ, 08854


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



5.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 03-16-2018 01:27 PM

Webinar: Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity

 May 9, 2018 from 10:00 AM to 11:00 AM (ET) 

Register through the link:

Overview

This Solution Provider Webinarr is brought to you by DIA in cooperation with

ArisGlobal


The regulatory and pharmacovigilance landscape is evolving substantially with the changing expectations from regulatory authorities. With the increasing number of drugs in the drug development pipeline and a parallel increase in the number of drugs being approved by major regulatory authorities globally, the costs continue to escalate. The pharma model for how clinical and safety data are acquired and managed throughout the lifecycle of a medicinal product needs to evolve and explore ways to decrease costs, increase efficiency, and achieve end-to-end (E-2-E) productivity. 

Drug development and pharmacovigilance have traditionally been predominantly human activities, recruiting large numbers of highly-trained and capable staff. Many hours of qualified staff are taken up performing routine and manual activities. Automation, however, has the potential to transform the current drug development and pharmacovigilance processes. With the incorporation of advanced automated technologies, several manual repetitive tasks can be automated. Therefore, highly-trained staff can focus on higher value work, consequently replacing, in some areas, roles that are entirely transactional.

This webinar will:

  • Detail how organizations can counter the current challenges in regulatory management and pharmacovigilance
  • Discuss how businesses can become more sophisticated by adopting state-of-the-art cognitive computing processes into their existing systems
  • Address how cognitive computing technologies can automate a multitude of tasks in pharmacovigilance and regulatory, including productivity, compliance, and data quality


Continuing Education Credits are not available for this event.

Featured topics

  • Scope of automation in E-2-E regulatory and pharmacovigilance activities
  • Application of cognitive computing technologies in case-processing, including data entry, medical review, and literature surveillance
  • How pharmacovigilance systems can help achieve compliance with changing regulations
  • Understanding the expected productivity gains with the adoption of newer technologies in E-2-E processes
  • How quality of case-processing can be much better using cognitive computing and robotic process automation
  • Possibilities and probabilities of automation supporting regulatory transformation

Who should attend?

Professionals who work in the area of:
  • Pharmacovigilance and Regulatory department business heads, and staff
  • Staff working on submissions targeting major regulatory authorities
  • QPPVs, Other business users. IT representatives may get some useful inputs
  • Medicinal product scope includes - Drugs, Devices, Vaccines and Cosmetics

Learning objectives

At the conclusion of this webinar, participants should be able to:
  • Describe the role of automation in the day-to-day E-2-E pharmacovigilance to regulatory activities
  • Evaluate the impact of successful automation in conducting the case-processing tasks
  • Describe how automated technologies can enable better compliance with the regulations than the traditional systems
  • Provide evidence of how automation technologies can solve persistence and perennial issues around data quality in systems
Online Instructions:
Url: http://engage.diaglobal.org/SPW-ArisGlobal-Practical-Use-Cases-of-Automation-in-Pharmacovigilance.html?_ga=2.237272002.395181042.1521122933-620165103.1521122933 
Login: Please log in through the link below and register for the event. Information on how to access the webinar will be emailed to you once you complete the registration.


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



6.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 25 days ago
Hello Everyone!

Are you interested in hearing cutting-edge information presented by some of the industry's leading experts from the comfort of your home or office?  Then consider watching one of DIA's Solution Provider Webinars!  They are complimentary and you can either watch them live or watch past webinars that have been recorded through the link below.

DIA - Solution Provider Webinars

We have presentations from companies including Microsoft, AirsGlobal, MMS, Generis, and more covering everything from Automating Regulatory Affairs, to Cloud Compliance, sample storage, and some future innovations that are influencing the industry.


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



7.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 24 days ago

Professional Development Webinar with Minnie Baylor-Henry , the President of B-Henry & Associates May 3rd, from 12-1PM EST



Please join us for our seventh Professional Development Webinar, on May 3rd, from 12PM EST to 1PM EST, featuring Minnie Baylor-Henry, JD, RPh, President of B-Henry & Associates, a regulatory life sciences consulting firm.

She will be sharing some of her career experience as well as advice for moving forward in the field. After her introduction and talk webinar guests will be welcome to ask Minnie questions and advice. Her short biography has been included below. We hope to see you at the meeting!

You can click the link below to register for the webinar (you will not be able to participate in the call unless you register).  It is free to join and we would love to have you there!

Professional Development Webinar with Minnie Baylor-Henry, JD, RPh, President, B-Henry & Associates

MINNIE V. BAYLOR-HENRY is the President of B-Henry & Associates, a regulatory life sciences consulting firm. In addition, she is the Executive Partner and Medical Devices Practice Leader for YourEncore, a leading provider of life sciences expertise. Prior to assuming her current roles, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson's (J&J) Medical Devices & Diagnostics business (2011-2015). Before returning to J&J in January 2011, Ms. Baylor-Henry was a National Director for Regulatory & Capital Markets Consulting at Deloitte & Touche. From 1999-2008, she worked in many executive leadership roles at J&J in the Pharmaceutical and Consumer businesses. Prior to joining J&J, Ms. Baylor-Henry worked for the US Food & Drug Administration (FDA). Ms. Baylor-Henry previously served as the Board Chair for the Food and Drug Law Institute (FDLI), as well as the President and Chair of the Board for the Drug Information Association (DIA). Currently, Ms. Baylor-Henry serves on the Board of Directors for Howard University, Dress for Success Boston, The Partnership, and the American Society of Health-System Pharmacists Foundation, as well as the Board of Visitors for Howard University's College of Pharmacy. Ms. Baylor-Henry received her Pharmacy degree from Howard University's College of Pharmacy and her law degree from Catholic University's Columbus School of Law.



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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



8.  RE: Announcements: Please post announcements that you have here!

Posted 23 days ago
These are great. Thanks for sharing!

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Obi Okafor
CERSI Fellow
Stanford University/UCSF
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9.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 19 days ago
DIA Facebook Student Group
Stay up to date on the latest podcasts, articles, and DIA activities!  Follow the DIA Student Group Facebook Page!

https://www.facebook.com/groups/DIAStudents/

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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



10.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 17 days ago
FDA's Office of Generic Drugs has partnered with DIA's Regulatory Affairs Community to offer a complimentary educational series focused on opportunities and challenges in the development of complex generic drugs. Registration is open for the last two webinars:

Employing Innovative Methodologies in the Development of Generic Drugs with Transdermal Delivery Systems
Speaker: Sam Raney, Ph.D. Chemist in the Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs at FDA
April 25 @ 2:00 PM ET
REGISTER
 http://engage.diaglobal.org/Generics-Webinar-Series-3.html

Pioneering Modeling Methodologies in Generic Drug Development
Speaker: Liang Zhao, Ph.D. Director of the Division of Quantitative Methods and Modeling in the Office of Research and Standards, Office of Generic Drugs at FDA
May 17 @ 1:00 PM ET
REGISTER 
 http://engage.diaglobal.org/Generics-Webinar-Series-4.html

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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



11.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 16 days ago

Calling all students and emerging professionals for publication opportunities!

DIA is looking for student- and emerging professional-authored submissions to the Career Column in our monthly online publication, Global Forum. This is your opportunity to share your career advice, information on an interesting topics, or publish your own thought pieces! 

Articles must be a maximum of 500 words and should be submitted to globalforum@diaglobal.org.

Below is a list of potential topic ideas though we are more than open to any topics that you propose! We are even willing to help and work with you on shaping your piece. This is your chance to get published and shine!

Topic Ideas Include:

  • Pick a hot topic in your field and write a perspective! It could be anything from CAR T-Cell Therapy, to the future of Real World Evidence, Artificial Intelligence, companies like Amazon becoming PBMs, or anything else that you think is interesting and important.
  • Any career advice on what works for you in your own career or studies. Do you have any tips or tricks that aren't part of the standard recommendations?
  • How do you tackle the challenges in today's market?
  • Are you working in a career that's considered non-traditional for your education? How did you end up there, how did you make the transition, etc.?
  • Student Chapters: write about the events that you have planned and held. DIA would love to hear about your activities!
  • Interviews/short Q&A with experts in your field
  • What does your career trajectory look like in your country? You might be surprised at how different it is across the globe!
  • A historical perspective on the changing roles of your profession
  • Propose your own topic!

If you have any questions or ideas please feel free to email us at globalforum@diaglobal.org.



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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



12.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 8 days ago

Student and Emerging Professional Forum at the DIA 2018 Global Annual Meeting!

RSVP for the Complimentary Student and Emerging Professional Forum at the DIA 2018 Global Annual Meeting!

RSVP to save your spot! 

Interact with fellow students and emerging professionals and receive guidance from seasoned professionals on their advice on how to grow in your career!

Sunday, June 24 | 10:30AM-12:00PM | Westin Waterfront
This Forum will include a panel discussion on potential careers for students with a scientific and/or healthcare background and advice on how to grow in your career. It will also explore the opportunities that student and emerging professionals receive through membership with DIA. Hear an overview of DIA and its relationship to the global pharmaceutical, device, and therapeutic industries, as well as the ways that you can network and get involved in DIA activities. 
Agenda
  • 10:30-10:45AM - Welcome and Introduction to DIA
  • 10:45-11:30AM - Interactive Career Panel Discussion
  • 11:00AM-12:00PM - Q&A Session

Fill out the form to confirm you will attend this free event!


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------



13.  RE: Announcements: Please post announcements that you have here!

DIA Staff
Posted 3 days ago
Edited by Katherine Krauland 3 days ago
Are you interested in learning more about the DIA 2018 Global Annual Meeting in Boston?

Then watch the Global Annual Meeting Webinar that talks about some of the meeting highlights and details that might interest you.  You can find the video in the library under Global Annual Meeting Webinar, or through the link below!

GAM Webinar!


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Katherine Krauland
Special Projects Lead
DIA
Washington DC
+1(202)601-8904
------------------------------