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The LORENZ Life Sciences Group is pleased to announce that this year's annual conference will be held in Lisbon, Portugal, September 23-25, at the Sheraton Lisboa Hotel & Spa.

 
 
Coming Up...
Tue, Sep 22nd, @8:00am - 05:00PM
22.-24. userBridge 2009
Wed, Sep 23rd, @8:00am - 05:00PM
22.-24. userBridge 2009
Thu, Sep 24th, @8:00am - 05:00PM
22.-24. userBridge 2009
 
With LORENZ and docuBridge we already see what regulators will later see while we are still assembling a new submission [...] 
 
Event News: DIA EDM Conf. Feb 2009 Philadelphia; DIA Dec 2008 Mumbai now Feb 2009
Tuesday, 04 November 2008

2008 and 2009 Regulatory Affairs Event Information Calender:
Regulatory affairs management and eCTD submissions to the FDA, HC, EMEA, and PMDA receive special attention in 2009

LORENZ provides Regulatory Affairs Events i.e. Conferences, Exhibits, Workshops, Training, etc. as a public service for the information and educational needs of the worldwide professional regulatory affairs community.

Topics cover e.g. compliance with regulatory affairs requirements e.g. marketing authorization applications, eCTD and Lifecycle submission management (e-Regulatory Affairs), and a variety of issues relevant to professional regulatory affairs management.

Validity of all mulit-event oganizer information listed here can not be guaranteed. More detailed event specific information can be found in the soon to be published 2009 event section of this website.

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2008 International Regulatory Affairs Events

Nov. 24-25 - DIA European Regulatory Affairs Forum 2008 in Munich, Germany
Dec. 03-05 - DIA 9th Conference on European Electronic Document Management in Barcelona, Spain - Booth 13
Dec. 05-05 - Bio Deutschland "Benefit Event for the Needy" in Berlin, Germany (This event has LORENZ support)
Dec. 08-10 - DIA 3rd Annual Conference on Drug Discovery and Clinical Development in Mumbai, India  -  Details
NEW DATE
The postponed Dec DIA Confenrence in Mumbai has now been moved to Feb 25-28 in Powai, Mumbai, India
Feb 25-28 - DIA 3rd Annual Conference on Drug Discovery and Clinical Development in Mumbai, India



 

2009 Regulatory Affairs Events listed by dates according to regions: North America, Europe, and Asia 

2009 Regulatory Affairs Events North America – USA and Canada

Jan 11-14 – DIA Regulatory Affairs: Part I:The IND Phase and Part II: The CTD/NDA Phase in Irvin, USA
Jan 12-15 – DIA 8th Annual Conference for Contemporary Pharmacovigilance & Risk Management Strategies in Wash. DC, USA
Jan 26-27 – DIA European Regulatory Affairs in San Francisco, USA (Training)
Feb 10-12 – DIA 22nd Annual Conference for Electronic Document Management - Philadelphia, PA USA Details
                     Visit LORENZ booth 208
Feb 16-18 – DIA CMC Regulatory & Tech. Strategies: Global CMC Dossier Life Cycle Management - Bethesda, USA
Feb 23-25 – QUMAS Connect, Worldwide User Conference 2009 in Tampa, FL, USA
Feb 23-26 – RAPS Executive Development - Haas School of Business at UC Berkeley in Berkeley, USA
Mar 02-04 – DIA 29th Annual Workshop on Medical Communications: Past, Present, and Future in Hilton Head Island, SC, USA
Mar 09-11 – DIA 24th Annual Data Conf. & Exhibit: Clinical Data Lifecycle Trial Design ...Submission + Beyond - Philadelphia, USA
Mar 23-25 – DIA Regulatory Affairs Part I: The IND Phase in Baltimore, USA
Apr 01-03 – RAPS Horizons Conference & Exhibition 2009 in San Francisco, USA
Apr 05-08 – HIMSS09 Healthcare Information and Management Systems Society Conference in Chicago, USA
Apr 23-23 – PDA Annual Meeting 2009 in Las Vegas, Nevada USA
Apr 27-30 – DIA Regulatory Affairs Part I: The IND Phase and Part II: The CTD/NDA Phase in Atlanta, USA
May 18-21 – Bio International Convention 2009 in Atlanta Georga, USA
May 20-22 – DIA Regulatory II: The CTD/NDA Phase in Baltimore, USA
Jun 15-18 – RAPS Executive Development Kellogg School of Management in Evanston, Illinois
Jun 21-25 – DIA 45th Annual Meeting in San Diego, California USA - Visit LORENZ booth 304
Sep 13-16 – RAPS Annual Conference & Exhibition 2009 in Philadelphia PA, USA - Visit LORENZ


2009 Regulatory Affairs Events Europe

Jan 27-28 – Informa 7th Annual Global Pricing and Reimbursement Congress 2009 Budapest, Hungary
Feb 03-04 – FORUM MR- & Dezentrales Verfahren in Bonn, Germany
Feb 10-10 – Microsoft Digital Pharma & Life Sciences Konferenz 2009 in Wiesbaden, Germany
Feb 10-12 – TOPRA MSc in Regulatory Affairs: Module 6 - Regulatory Strategy: The Market Place in Frankfurt, Germany
Feb 12-12 – TOPRA Basics of Regulatory Affairs in London, UK
Feb 23-26 – Informa Lifecycle Management of the eCTD in Brussels, Belgium
Feb 24-26 – TOPRA MSc MTRA: Module 7 - US Regulation of Medical Technology in Cranfield, UK
Feb 25-26 – TOPRA EU Commission - proposals for new Pharmaceutical Legislation in Brussels, Belgium
Feb 27-27 – FORUM Non-eCTD electronic Submissions (NeeS) in Frankfurt, Germany
Mar 23-25 – DIA 21st Annual Euro Meeting in Berlin, Germany - Visit LORENZ booth 1409 Details
Mar 29-03 – TOPRA Spring Regulatory Affairs Introductory Course in Croydon, UK
May 12-13 – DGRA Jahreskongress 2009 in Bonn, Germany
May 14-14 – TOPRA Basics of Regulatory Affairs in London, UK
May 14-15 – DIA An Introduction to Product Information Management (PIM) in London, UK
Jun 03-05 – Bio Tech B2B opportunities in Lodz, Poland
Jun 16-18 – TOPRA MSc in Regulatory Affairs: Module 8 - Data Requirements for ... in Edinburgh, Scotland
Aug 13-13 – TOPRA Basics of Regulatory Affairs in London, UK
Sep 22-24 – TOPRA MSc MTRA: Module 1 - Principles of European Medical Technology Regulatory Affairs in Cranfield, UK
Sep 22-24 – LORENZ Annual User Conference userBridge 2009 for Industry and Regulatory Affairs Agencies in Warsaw, Poland
Oct 06-08 – Biotechnica in Hannover, Germany - Visit LORENZ
Oct 07-09 – TOPRA 6th Annual Symposium in Stockholm, Sweden - Visit LORENZ
Oct 15-15 – TOPRA Basics of Regulatory Affairs in London, UK
Oct 19-22 – DIA US Regulatory Affairs in Basel, Switzerland
Nov 01-05 – TOPRA Autumn Regulatory Affairs Introductory Course
Nov 20-20 – TOPRA Risk Based Approach to Regulatory Affairs
Dec 08-10 – TOPRA MSc MTRA: Mod. 2 - Design, Development and Testing of Medical Technology in Cranfield, UK

2009 Regulatory Affairs Events Asia and Middle East (India, Japan, Bahrain)

Jan 20-21 – DIA 8th Middle East Regulatory Conference - MERC 2009 in Manam, Bahrain

Jan 29-30 – DIA 12th Annual Workshop for CLINICAL DATA MANAGEMENT: Who should Be "Superman" in CDM? In Tokyo, Japan
Feb 25-28 - DIA 3rd Annual Conference on Drug Discovery and Clinical Development in Mumbai, India -  Details
                    Visit LORENZ booth 15
May 28-29 – DIA 3rd Asia New Drug Development Exhibition in Tokyo, Japan
Jul 01-03 – Interphex Internat. Pharma Cosmetic & Detergent R&D & Manufacturing Technology Expo / Conf. in Tokyo, Japan
Jul 01-03 – Reed INT'L BIO FORUM & BIO EXPO  in Tokyo, Japan
Sep 29-01 – Analytica Anacon India in Hyderabad, India

e-Regulatory and eCTD Software Solutions being presented:
LORENZ docuBridge®; eCTD Validator™; drugTrack™; labelBridge®; and authorBridge™.
 
Learn more about why LORENZ docuBridge® is the number one choice as e-Regulatory Affairs eCTD and Product LifeCycle Submission Management System.


Visit LORENZ at one of the upcoming conferences and exhibitions or just drop your regional contact a line for a personal appointment.

Contact: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
LORENZ Life Sciences Group: Serving you in North America, Europe, and Asia

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LORENZ announces end of year eCTD Submission Management System Workshops
Sunday, 02 November 2008
LORENZ announces end year eCTD Submission Management System Workshops

November 2008 Workshops Frankfurt
Nov 25 and/or 26 – Basic Training    Still open (max. 12 participants)
Nov 27 and/or 28 – Advanced Training     Still open (max. 12 participants)

December 2008 Workshops Frankfurt
Dec 2 and/or 3 – Basic Training    Booked out (max. 19 participants)
Dec 4 and/or 5 – Advanced Training    Still open (max. 12 participants)
Read more...
 
LORENZ launches eCTD 1K Club
Wednesday, 08 October 2008

The LORENZ Life Sciences Group announced the launching of the eCTD "1K Club". The 1K club pays tribute to a number of LORENZ docuBridge® customers who have already passed the 1,000 e-Submissions mark.

In May 2008, one US based customer alone became the first company to have 1,000 eCTDs submitted to the FDA. Since then, several companies reported in September 2008 at the international LORENZ annual user conference in Lisbon that they too have broken the 1,000 eCTD submission mark.

The number of customers around the world who have already submitted over 1,000 eCTDs increases. The  LORENZ docuBridge® platform contnues to be the most used eCTD software platform i.e. Submission Management System for thousands of marketing authorization applications (MAA) and eCTD electronic submissions to regulatory affairs agencies in the USA, Canada, Europe, and Asia. Making records and breaking records, LORENZ remains the #1 global eCTD solution for agencies, companies, and consultants who want the most proven performance and reliability available for e-regulatory affairs management.

Read more...
 
LORENZ 2008 User Conference and Regulatory Affairs Inter-Agency User Meeting
Wednesday, 01 October 2008

September 2008: LORENZ has successfully concluded its 6th LORENZ user conference, userBridge 2008.  The conference was held at the Sheraton in Lisbon and included delegates from all over the world, from industry, as well as from regulatory agencies.

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Read more...
 
Adlib Software and LORENZ Life Sciences Sign OEM Agreement
Monday, 23 June 2008
LORENZ to Bolster e-Regulatory Offering with Adlib ExpressConversion Technology
Read more...
 
Highlighting record-breaking Performance at DIA in Boston, June 22-25 – Booth 334
Wednesday, 04 June 2008
The LORENZ Life Sciences Group highlights record-breaking performance with an invitation to visit the DIA 44th Annual Meeting in Boston. Be sure to mark LORENZ Booth 334 as the place to go in the summer of 2008. To sneak preview what’s in store for you ....
Read more...
 
LORENZ Life Sciences Group announces the adoption of GAMP5
Wednesday, 21 May 2008

The LORENZ Life Sciences Group announces the adoption of GAMP5 practices for key internal quality systems with target date for full implementation by the end of 2009.

Read more...
 
LORENZ Life Sciences Group and REGXIA Announce Collaboration in Canada
Thursday, 19 June 2008
LORENZ Life Sciences Group, the worldwide leading provider of pharmaceutical submission management solutions, and REGXIA, a unique scientific and regulatory consulting firm providing solutions for all phases of a products’ life-cycle, announced today they will begin working together in the Canadian market.
Read more...
 
EMEA Implementation of electronic-only submissions in the centralised procedure
Tuesday, 22 January 2008

Frankfurt, Germany and London, UK, 22nd January 2008


The European Medicines Agency (EMEA) - has today announced that electronic-only submissions will be accepted at the latest by 1st July 2009.

Read more...
 
LORENZ Life Sciences Group and MasterControl Integration
Monday, 17 December 2007
SALT LAKE CITY– December 13, 2007– MasterControl Inc. announced the development and availability of an integration tool that connects with LORENZ Life Sciences Group submissions management solutions. The integration product improves life science companies’ ability to manage electronic submissions to the FDA and similar regulatory agencies.
Read more...
 
Practical eCTD training from iRegulatory and LORENZ Life Sciences
Thursday, 15 November 2007
LORENZ Life Sciences, a worldwide leading provider of pharmaceutical submission management solutions, and iRegulatory Ltd, a successful and expanding European pharmaceutical regulatory affairs consultancy with a track record in contract regulatory publishing, announced today the establishment of their joint venture (JV) partnership targetted to provide training and workshops to regulatory professionals in the pharmaceutical industry.
Read more...
 
Orchid Chemicals & Pharmaceuticals Ltd. choose docuBridge as their eCTD Publishing and Management So
Tuesday, 30 October 2007
The LORENZ Life Sciences Group announced today that Orchid Chemicals & Pharmaceuticals, located in Chennai, India has chosen docuBridge as its eCTD Publishing and Management solution. Orchid’s scientific and technical strengths have made it a partner of choice for several multinational corporations. Orchid has long-term exclusive marketing alliances with reputed global companies such as Apotex, Actavis, Dava and Hospira for distribution of Orchid’s products in the advanced markets of US and Europe.
Read more...
 
LORENZ Life Sciences Group and MasterControl Announce Strategic Alliance
Monday, 17 September 2007

SALT LAKE CITY– September 12, 2007– MasterControl Inc. today announced that it has entered into a strategic partnership with LORENZ Life Sciences Group. The partnership will facilitate the development of integration strategies that will improve life science companies’ management of their electronic submissions to the FDA and similar regulatory agencies.

Read more...
 
Fulcrum and LORENZ in strategic alliance to develop and deliver “Creative eRegulatory Solutions™”
Friday, 07 September 2007
Fulcrum Pharma plc (AIM: FUL), the drug development and regulatory services company, is pleased to announce the intent to form a strategic alliance with LORENZ Life Sciences Group.
Read more...
 
LORENZ unveils its powerful new ASP Service
Monday, 19 February 2007

LORENZ Life Sciences Group, the leading innovator in submission management, has announced the release of docuBridge.ASP 2.0, a world-class web-enabled service to the Global Life Sciences Industry.

Read more...
 
LORENZ announce partnership with Iperion BV
Friday, 27 April 2007
LORENZ Life Sciences Group, the leading global innovator in submission management solutions, has proudly announced that it has formed a new partnership with Iperion BV.
Read more...
 
LORENZ releases new eCTD Validator
Thursday, 03 May 2007
The LORENZ Life Sciences Group announced the availability of the new standalone eCTD Validator 2.0.
Read more...
 
Answerthink and LORENZ Life Sciences Group Announce Strategic Alliance
Thursday, 07 June 2007
Answerthink, Inc. (NASDAQ: ANSR), announced that it has formed a strategic alliance with LORENZ Life Sciences Group for the distribution of LORENZ solutions in North America.
Read more...
 
LORENZ Announces Introduction of authorBridge™ Templates
Friday, 15 June 2007
LORENZ announces the introduction of authorBridge™ templates that facilitate authoring processes during the content creation for regulatory submissions.
Read more...
 

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