Navigation Links
LORENZ' Response to New EU PV Legislation - Regulation No. 1235/2010 and EVMPD
Date:11/2/2011

FRANKFURT AM MAIN, Germany, Nov. 2, 2011 /PRNewswire/ -- LORENZ customers and business partners have successfully completed the first workshop on the new Requirements of Article 57(2) of Regulation (EC) 726/2004 and its impact on the industry. This marked the start of the LORENZ Special Interest Group for EVMPD – XEVPRM.

One of the hot topics in the regulated market space of drug registration are the Requirements of Article 57(2) of Regulation (EC) 726/2004. Since the EU has mandated the European Medicines Agency (EMA) to build a database for all registered product information within the European Union, many organizations are discussing and planning how to cope with the challenge to supply relevant data within a very aggressive time schedule. The legislation is effective and mandatory as of 2nd July 2012. A quote from the EMA website reads: "The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorizations."

With this in mind, a strategic group of LORENZ customers and business collaborators came together on 24th October 2011 at LORENZ Headquarters in Frankfurt, Germany. In this workshop the complexity of the undertaking became clear, and the challenging timelines were reviewed.

"The data model, ease of use and proven track record of supplying a data entry platform will be key for our customers and coworkers", says Wolfgang Witzel, President of LORENZ Life Sciences Group. "There are several facts that we have to accept. Firstly, the draft specification has only been available since 1st September 2011. Secondly, further guidance is outstanding and questions on the specification still needs to be answered. Thirdly, example messages are outstanding. Fourthly, vocabularies are outstanding. And finally, on the technology side, both the Gateway and EVWeb supplied by EMA are not ready. This is a h
'/>"/>

SOURCE LORENZ Life Sciences Group
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Directors Forum: PEPFAR and the Global AIDS Response
4. Interim Response and Safety Analyses Support Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-Cell Lymphoma
5. Abbotts ABT-874 Shows Positive Results for Maintenance of Response in Phase II Psoriasis Study
6. Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response
7. Preclinical Studies Show Potential Progress Toward Identifying Specific Tumor Types With Higher Likelihood of Demonstrating Response to Anti-Cancer Compounds Early in Clinical Development
8. MedicAlert Foundation Joins The Alzheimers Association to Offer MedicAlert(R) + Alzheimers Association Safe Return(R) - Live 24-Hour Emergency Response for Wandering and Medical Emergencies
9. Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Methotrexate
10. Caliper Life Sciences Introduces Drug Combination Services to Identify Synergistic Response of Compounds
11. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... 2015 TWi Pharmaceuticals, Inc. ("TWi", Stock Ticker:4180.TT) ... USA , has obtained state sales licenses ... has been in close contact with the major nationwide ... its own label specialty generic products sold through these ... market. According to IMS Health, the U.S. ...
(Date:4/16/2015)... April 16, 2015  Hologic, Inc. (NASDAQ: ... screening study i published on-line this week ... of the American Cancer Society. The ... of Pittsburgh Medical Center, supports current consensus guidelines ii ... women 30-65 years of age be co-tested with ...
(Date:4/16/2015)... Kenneth C. Frazier , chairman and chief executive officer ... the Board of the Pharmaceutical Research and Manufacturers of America ... John J. Castellani announced that he will be retiring ... to PhRMA Board Frazier formerly held the position ... and CEO of Pfizer, Inc. Also elected were George ...
Breaking Medicine Technology:Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 2Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 3Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 4Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 2Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 3Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 4Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 5
(Date:4/18/2015)... April 18, 2015 Compare-autoinsurance.org has released ... reliable auto insurance policy . , Clients ... car insurance quotes online is safe and reliable. An ... The quotes are displayed on a single web page, ... , It is now possible to compare online ...
(Date:4/18/2015)... PITTSBURGH, PA (PRWEB) April 18, 2015 ... so I decided to create a healthful juice ... an inventor from Rosedale, Md. "It increases my ... overall healthy body." , He developed Tapp's Juice ... The juice helps to prevent physical and mental ...
(Date:4/18/2015)... 2015 Patients who undergo radiation for ... later in life, but the disease is likely to ... unrelated to radiation. Surviving Mesothelioma has just posted the ... Click here to read it now. , Scientists ... of 45 patients who had both a hematologic cancer ...
(Date:4/18/2015)... NE (PRWEB) April 18, 2015 ... in healthcare staffing, including physical therapy jobs, has ... at the South Carolina Physical Therapy Association Annual ... the Kroc Center in Greenville, SC. , ... opportunities, and exhibits with products and services. ...
(Date:4/17/2015)... 17, 2015 John Evans, a Gardant ... the Patio from 2 p.m. to 3 p.m. on ... 1320 Executive Ct. in Pekin, Illinois, serves older adults ... some help to maintain their independence. , Becky Baker ... treats will be served during the luau. , For ...
Breaking Medicine News(10 mins):Health News:A Guide For Avoiding Online Auto Insurance Scams! 2Health News:New Study Examines Relationship Between Radiation for Hematologic Cancers and Development of Mesothelioma, According to Surviving Mesothelioma 2Health News:Healthcare Staffing Leader, Aureus Medical Group, to Exhibit at the South Carolina Physical Therapy Association Annual Conference 2Health News:John Evans Supportive Living Community Prepares for Party on the Patio 2
... avoid dreaded "doughnut hole" , , WASHINGTON, June 23 ... million older Americans will have fallen into the "doughnut hole"--a ... on the hook for all of their own drug costs ... online resource to help older Americans avoid this dreaded coverage ...
... giving the Food and Drug Administration (FDA) the power to ... House ceremony today. , , (Logo: ... government can now regulate the amount of nicotine in tobacco ... detailed on the label and prohibit deceptive marketing and ads ...
... most frequent congenital abnormality of the small bowel and ... asymptomatic but approximately 4% are symptomatic with complications such ... al presents a case of Meckel,s diverticulum masked by ... foundings will be published on June 14, 2009 in ...
... Ont., June 23, 2009 While Ontario women live ... suffer from disability and chronic conditions, according to a ... Dr. Arlene Bierman. What,s more, low-income women have more ... than women in high-income groups. While inequities in ...
... President,s Council of Economic Advisors, Authors New Report Titled "Who ... Today the Employment Policies Institute (EPI) released a new study ... uninsured Americans is a misleading representation of the problem. The ... Baruch College and City University of New York ...
... ... and Answers: Does Your State Have the Healthiest Brains? , ... Columbia, MD (Vocus) June 23, 2009 –- ... just how “brain smart” Americans are and points to simple actions they can take ...
Cached Medicine News:Health News:AARP Launches Money-Saving Prescription Drug Resource 2Health News:AARP Launches Money-Saving Prescription Drug Resource 3Health News:Lung Cancer Alliance Hails Signing of Tobacco Control Legislation Into Law; Urges Action on Lung Cancer 2Health News:Ontario women live longer but don't prosper: Study 2Health News:Ontario women live longer but don't prosper: Study 3Health News:Ontario women live longer but don't prosper: Study 4Health News:New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated 2Health News:New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated 3Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 2Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 3Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 4Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 5Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 6Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 7Health News:First Brain Health lndex Ranks America's “Brain Smarts” Based on 21 Indicators: D.C. Ranks No. 1 8
... new software upgrade including fourSight 4D ultrasound ... system offers a wide variety of imaging ... management features that combine to expand the ... ,The Antares system was built on four ...
... evolution in stent technology with no compromises. ... balloon-with great-looking results. With S670's discrete, low-profile ... deliver the excellent clinical results you want. ... with no compromises. It's the stent that ...
Increased stent scaffolding at the proximal end gives optimal lumen support and 6F guide catheter compatibility and improved tracking offer excellent deliverability. Customized balloon lengths for ea...
For support, strength and control in your interventions, the RunWay Guide Catheter's large lumen and high-performance design represents a new era in guide catheters....
Medicine Products: