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 huge challenge for industry."

"As a result, LORENZ believes this has to be planned carefully and adapted as the specification and guidance becomes more mature. It also means that any organisation offering a final solution today cannot be providing a serious offer and the buyer will possibly be paying a premium," Wolfgang Witzel continues.

Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, added, "LORENZ has the track record of being the most innovative provider of quality software and related services for e-regulated processes in the Life Sciences industry. As a result, LORENZ too will look into options in providing a validated product for this important process as well.  The ultimate goal is to comply to the future ISO IMPD standard, recognizing that the XEVPRM is an interim standard."

Further information about the meeting, progress of work and timelines will be distributed and can be accessed via LORENZ ID as of December 2011.

About LORENZ Life Sciences Group LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 200 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.


'/>"/>
SOURCE LORENZ Life Sciences Group
Copyright©2010 PR Newswire.
All rights reserved

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:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) announced ... Act of 1976, as amended ("HSR"), with respect to ... CPXX ) expired effective June 24, 2016, ... previously announced on May 31, 2016, Jazz Pharmaceuticals and ... Jazz Pharmaceuticals has commenced a tender offer for all ...
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... TherapySites, the leading website and ... Tennessee Counseling Association. This new relationship allows TherapySites to continue to extend ... exclusive benefits and promotional offers. , "TCA is extremely excited about this new ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their ... Eyeglasses . , Millions of individuals in the United States and Canada wear eyeglasses. ... way to both correct vision and make a fashion statement. Even celebrities use glasses ...
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
Breaking Medicine News(10 mins):