Navigation Links
CfPIE’s Newest Training Course Facilitates Life Science Professionals in Staying Current with FDA Approval Trends
Date:12/18/2012

Malvern, PA (PRWEB) December 18, 2012

The Center for Professional Innovation and Education (CfPIE) has introduced a new course, Recent FDA Approval Trends: What You Must Know, to help pharmaceutical and biotechnology professionals stay abreast of evolving regulatory trends. The comprehensive, two-day course will be presented on January 28-29, 2012 at the Doubletree Valley Forge in King of Prussia, Pennsylvania.

Addressed are cost-effective strategies and tactics for keeping track of developments in FDA approvals and the latest requirements in a complex regulatory environment to avoid the consequences of non-compliance. It breaks down information compiled from the Tufts Center for the Study of Drug Development (Tufts CSDD) and from consultant and government reports into perspectives for individuals working across a broad range of disciplines. This content holds particular importance for those in clinical development, translational medicine, regulatory science, regulatory affairs, risk management, clinical/regulatory informatics, statistics, strategic planning, and project management.

The curriculum covers current trends and provides insights into how they translate into the future. It also compares tactics adopted by competitors as well as trend variations within therapeutic areas and product types. Key topics include basic approval trends for NMEs, NDAs, BLAs, and Supplements; special product designations/programs; regulatory science and ‘next wave’ product approvals; the impact of FDA and Sponsor workload on approval trends; factors that may introduce bias into the approval process; and what PDUFA’s past tells us about its future.

About CfPIE
The Center for Professional Innovation and Education (CfPIE) is the global leader in profess
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. Two Baltimore Business Leaders are BioHealth Innovation, Inc.s Newest Board Members
2. Clinical Site Services Chris Trizna Contributing Author in Diana Anderson-Fosters Newest Release Global Issues in Patient Recruitment and Retention
3. Vision Research Introduces the Newest Member Of the Phantom®- 1Mpx- v-Series Camera Family
4. Autoimmune disease retraining white blood cells
5. Veridiams Training Program Wins Accolades and Awards- Meets Skilled Labor Challenge Head On
6. Queens Volunteer Firefighters Receive Mold Removal Training; IgotMold Recommends Use of Molderizer to Make the Process Effective and Safe
7. NPL named by Semta as a top training provider
8. Online Training for Hospital Value Based Purchasing Now Available
9. The Spring 2012 MediSend Biomedical Repair Training Program™ Sends Graduating Biomedical Technicians to Hospitals Around the World
10. Covenant Security Services and the Department of Homeland Security Partner to Provide Nationwide Training on Active Shooter Awareness and Response
11. Fluke Biomedical training center goes global: adds multi-language support
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2015)... , Aug. 31, 2015 LabStyle Innovations ... Management Solution, today announced it recently closed a ... will be used to support the global rollout ... a mobile, cloud-based, diabetes management solution that includes ... pocket-sized, blood glucose monitoring device, and for working ...
(Date:8/31/2015)... ... August 31, 2015 , ... ... world's most successful food and beverage processors, equipment manufacturers and leaders in the ... inspection and industrial weighing and formulation for manufacturers of bakery and snacks; beverages; ...
(Date:8/30/2015)... August 31, 2015 , ...   für chirurgische   Behandlung     ...   werden für eine   verheerende   Geburtsverletzung behandelt ... und die Anzahl ausgebildeter Chirurgen in Kenia bis 2017 ... heute bekannt, dass  Action on Fistula  seit ihrem Beginn ...
(Date:8/28/2015)... ... August 28, 2015 , ... Proove Biosciences , ... International Spine Intervention Society’ s 23rd Annual Scientific Meeting (ASM). The ... With a focus on evidence-based research and clinical application, the event gathered industry ...
Breaking Biology Technology:LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 2LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 3LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 4METTLER TOLEDO Hosts Food Safety Educational Center at 2015 PROCESS EXPO 2Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 2Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 3Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 4Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 5Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 2Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 3Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 4
... -- Researchers at the USDA Forest Service Forest Products ... the pulp and paper industry in an effort to ... paper commonly used in business and government offices ... federal government annually buys some 500,000 tons of bleached ...
... Third Wave Technologies , a developer and marketer of molecular ... patent infringement lawsuit against Stratagene Corp. , a life ... which was passed by a federal jury in the United ... that Stratagene's line of FullVelocity reagents had infringed on two ...
... in reality too, as an ultra-sophisticated, digitally formatted, ... in shapes of large digital cyber-warfare torpedoes skate ... direct hits took over. , ,Now there are ... either corporate elites or very smart solo entrepreneurs; ...
Cached Biology Technology:Reducing brightness to make a better paper 2Reducing brightness to make a better paper 3Third Wave wins patent lawsuit against California firm 2Cyber-skating on one flat earth 2Cyber-skating on one flat earth 3Cyber-skating on one flat earth 4
(Date:8/31/2015)... , Aug. 31, 2015 Research and ... the "Saudi Arabia Biomedical Sensors Market - Growth, ... The Saudi Arabia Biomedical Sensors market ... CAGR of 3.64% over the period 2014-2020 ... adaptable to the genetic formulation of each individual. These ...
(Date:8/26/2015)... PUNE, India , August 26, 2015 ... (Two, Three, Four, and Five Factor), Application (Travel & ... and Geography - Global Forecast to 2020", published by ... 9.60 Billion by 2020, growing at a CAGR of ... 71 Tables and 82 F igures spread through ...
(Date:8/24/2015)... Africa , August 24, 2015 ... Germany ,s largest biometrics manufacturer DERMALOG and its customized ... the "2015 African Biometrics Company of the Year Award". DERMALOG ... Nigeria .   -Cross reference: Picture ... http://www.presseportal.de/nr/8896 - On Thursday evening, in ...
Breaking Biology News(10 mins):Saudi Arabia Biomedical Sensors Market Report 2015 - Growth, Trends & Forecasts (2014-2020) 2Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 2Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 3Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 4Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 5Frost & Sullivan Honors DERMALOG with Biometrics Prize for Achievements in Africa 2Frost & Sullivan Honors DERMALOG with Biometrics Prize for Achievements in Africa 3
... issue of Differentiation, guest-edited by Brigid Hogan, highlights ... known as branching morphogenesis. Through a series of ... during animal development are revealed. The articles analyze ... in the same species. They also compare the ...
... the antibody that's the workhorse of the human immune ... the phagosomes that corral invading pathogens and the potent ... research, by Axel Nohturfft at Harvard University and colleagues ... of Technology, appears this week in the Proceedings of ...
... part of the international Census of Marine Life (CoML), ... an expedition to explore coral reef biodiversity in the ... Hawaiian Islands Marine National Monument. Led by the ... Science Center, with funding from NOAA's Coral Reef Conservation ...
Cached Biology News:A key antibody, IgG, links cells' capture and disposal of germs 2First Biodiversity Census of coral reef ecosystems in the NW Hawaiian Islands 2First Biodiversity Census of coral reef ecosystems in the NW Hawaiian Islands 3