OPENeCTD formerly - Extedo
OPENeCTD formerly - Extedo
OPENeCTD formerly - Extedo
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<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
eRegulatory Affairs 2011<br />
Get ready for the new ERA of electronic regulatory communications!<br />
CONFERENCE ANNOUNCEMENT<br />
13 – 14 April 2011<br />
BlueBay Galatzo Hotel, Peguera, Majorca, Spain
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
About the eRA (<strong>formerly</strong> <strong>OPENeCTD</strong> forum)<br />
A new name, but still essential: In 2011 we move beyond the<br />
usual eCTD topics and add other eRegulatory Affairs topics<br />
such as drug safety, labeling, registration management and<br />
document management. Due to our global presence we<br />
have also organized an additional event in North America<br />
(see www.era2011.org).<br />
The eRA2011 conference provides an ideal knowledge<br />
sharing opportunity, with a history of presenting key<br />
eRegulatory developments and the latest news around<br />
the eSubmis sion & Labeling standards by a distinguished<br />
panel of industry and authority speakers.<br />
The eRA2011 is organized in three specialized tracks<br />
covered by more than 30 domain experts.<br />
Gain valuable insights for your organization by learning<br />
about new eRegulatory developments and standards and<br />
case studies.<br />
Engage representatives from a variety of different<br />
organizations (industry & authority) in a stimulating and<br />
open environment about issues critical to your business.<br />
Get ready for the new ERA of electronic regulatory<br />
communications!<br />
Who should participate?<br />
eRA 2011 will particularly benefit professionals who work<br />
in Pharmaceutical Drug Regulatory Affairs or Dossier<br />
Assessment and Registration offices – directors and<br />
experts of regulatory affairs and dossier review, as well<br />
as IT managers focused on introducing IT systems for<br />
pharmaceutical regulatory processes. Experts who are<br />
involved in the compilation, publishing and reviewing of<br />
regulatory submissions will also benefit by attending.<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
2
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
Agenda: Wednesday, 13 April 2011 – Day 1<br />
08:00 – 09:30<br />
09:30 – 09:45<br />
09:45 – 10:15<br />
10:15 – 10:45<br />
• Registration<br />
• Opening eRA2011 – Tore Bergsteiner & Martin Schmid<br />
• Electronic Submissions in Europe – EMAs Roadmap and Vision – Hans Georg Wagner (European Medicines Agency)<br />
• eSubmission: The Good, The Bad, The Future – Michael Schaub (Regulatory Pharma Net)<br />
10:45 – 11:15 Coffee Break<br />
11:15 – 12:00<br />
12:00 – 12:30<br />
• Your eRegulatory World – Winds of Change – Steve Scribner (International Life Science Solutions)<br />
• Current Status of Electronic Regulatory Affairs Standards in Europe – Vito Strasberger (Nanokinetik)<br />
12:30 – 14:00 Lunch – sponsored by ProductLife<br />
14:00 – 15:30 A1 Submission Planning & Tracking – How to manage<br />
registrations<br />
• B.Braun´s View on an Integrated Regulatory<br />
Application Landscape and How to Get There –<br />
Harald Weis (B.Braun)<br />
• Swissmedic‘s Submission Tracking and Reviewing<br />
Now and in the Future – What is in it for the<br />
Applicants? – Susanne Kienberger (Swiss Authority,<br />
Swissmedic)<br />
• Submission Planning & Tracking of Agency<br />
Communication – Ruedi Blattmann (Life Science<br />
Consulting Partners, LSCP)<br />
B1<br />
EU-Regulation & Validation<br />
• Validation of eCTD and NeeS – An Industry<br />
Perspective – Alastair Nixon (GSK)<br />
• The Improved Validation Criteria – Karin Gröhndal<br />
(Swedish Authority, MPA)<br />
• e-Submission Validation in Europe – Balancing National<br />
Agencies‘ Requirements with an Applicants‘<br />
Desire for a Harmonized Dossier – Karl-Heinz<br />
Loebel (Pharmalex)<br />
C1<br />
Sponsoring Partner Track<br />
• Managing Electronic Submission Documents and<br />
Correspondence – Cyril Walsh (QUMAS)<br />
• From Paper-Dossier to eCTD – Andreas Treptow<br />
(Optimal Systems)<br />
15:30 – 16:00 Coffee Break<br />
16:00 – 17:30 A2 Customer Success Stories<br />
B2<br />
Worldwide Standards and Interoperability<br />
C2<br />
Sponsoring Partner Track<br />
• How to Replace Three Legacy eSubmission<br />
Systems with a New One – Adam Aparicio (Merck)<br />
• Global eSubmission management – act local and<br />
and think global – the Angelini Group experience –<br />
Maria Angela Gatto (Angelini)<br />
• CanReg’s eCTD Success Story and Lessons<br />
Learned – Ted Hanebach (CanReg)<br />
• Introduction to the IRISS Forum (Implementation<br />
of Regulatory Information Submission Standards) –<br />
Deanna Murden (ePharmaCMC, LLC)<br />
• An Update on the IRISS ETICS III Project: The EU<br />
Arm of the Study – John-Paul Smith (Celgene)<br />
• Electronic Submissions in the Far East –<br />
Harv Martens (EXTEDO)<br />
• Sharepoint Validation Services – Klavs Esbjerg<br />
(Epista IT)<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
3
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
Agenda: Thursday, 14 April 2011 – Day 2<br />
09:00 – 10:30 A3 Communicating with the Authorities (EiY User<br />
Group Meeting – Open Part)<br />
• How the Quality of Received Submissions Influences<br />
the Review Process at NCAs – Mickel<br />
Hedemand (Danish Authority, DKMA)<br />
• eSubmission in MRP/DCP – a Field Report.<br />
Discussion with the Audience – Petra Grundhöfer<br />
(KapplerConsult)<br />
B3<br />
Core-Dossier Management<br />
• Master – Dossier Management carried to the<br />
Extreme: Every Dossier needs a Master – Dr. Peter<br />
Rossmanith (BASF)<br />
• Planning Successful Multi-country electronic Submissions<br />
– Hans van Bruggen, eCTDconsultancy<br />
• The eCTD Experience at Synthon – Ellen Simons<br />
(Synthon)<br />
C3<br />
Pharmacovigilance in a new ERA<br />
• Recent Changes in US Regulations Regarding<br />
Clinical Trial IND – Jim Buchanan (BioSoteria)<br />
• Risk Management and the Future of Pharmacovigilance<br />
– Dr. Erick Gaussens (ProductLife)<br />
• Audits and Inspections in Pharmacovigilance –<br />
Focus on Electronic Systems – Dr. Reinhard Nibler<br />
(Dr. Nibler & Partner)<br />
10:30 – 11:00 Coffee Break<br />
11:00 – 12:30 A4 Regulatory Compliance Leveraging Outsourcing<br />
and Hosting Services<br />
• Case Study: Outsourcing from a Service Provider’s<br />
Perspective – Katrin Spaepen (Comply Services)<br />
• Using PcVmanager in a Hosted Environment –<br />
Prof. Dr. Paolo Biffignandi (Euvigilance)<br />
• An Efficient Platform for Drug Safety Management<br />
– EXTEDO’s Software as a Service –<br />
Prof. Dr. Tho mas Städter (EXTEDO)<br />
B4<br />
Structured Product Information<br />
• Structured Product Information with DITA – a well<br />
established XML standard since 2004 – Christian<br />
Kravogel (EXTEDO)<br />
• The US-Standard SPL – a solution for Europe too?<br />
Karl-Heinz Loebel (Pharmalex)<br />
• Podium Discussion: PIM / Structured Product<br />
Information – The ugly truth – Karl-Heinz Loebel<br />
(Pharmalex), Dr. Jaroslava Paraškevová (MEDA<br />
Pharma), Christian Kravogel (EXTEDO)<br />
C4<br />
EiY User Group Meeting – Authorities only<br />
• Introduction of EURS is Yours and First Reviewing<br />
Experiences – Eduardas Sizovas (Lithuanian<br />
Agency)<br />
• Agency perspective on validation – Pieter<br />
Vankeerberghen (FAGG)<br />
• ICI and EiY make it easy – Dr. Ricco van den Hoorn<br />
(MEB)<br />
12:30 – 13:00 Open Discussion between Industry and Agency Closing Remarks<br />
13:00 – 14:00 Lunch<br />
14:00 – 15:30 A5 eCTDmanager User Group Meeting<br />
B5<br />
PcVmanager User Group Meeting<br />
C5<br />
EiY User Group Meeting – Authorities only<br />
• New Features<br />
• Roadmap<br />
• Wishlist (open discussion)<br />
• New Features<br />
• Roadmap<br />
• Wishlist (open discussion)<br />
• New Features<br />
• Roadmap<br />
• Wishlist (open discussion)<br />
15:30 Final Conference Closing with Drinks and Snacks<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
4
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
eRA Initiator Gold Sponsor Silver Sponsors Bronze Sponsor Individual Sponsor<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
5
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
Information<br />
Location<br />
BlueBay Galatzo Hotel<br />
Carretera de Palma a Andratx, km 20<br />
07160 Paguera – Calvià, Islas Baleares, Spain<br />
Phone +34 971 68 96 00<br />
http://www.bluebayresorts.com/en/hotel/bluebay-galatzo.html<br />
Accommodation<br />
The BlueBay Galatzo Hotel has allocated a block of bedrooms at a special<br />
rate for attendees:<br />
Single room: EUR 105 / Double room: EUR 125 (per night)<br />
Please use this opportunity. Reservations have to be done via e-mail or fax<br />
with the specific hotel reservation form, available online: www.eRA2011.org<br />
–> Registration<br />
Registration<br />
Please register online: www.eRA2011.org –> Registration<br />
Contact<br />
eRA2011 Conference<br />
c/o EXTEDO GmbH<br />
Einsteinstrasse 30<br />
85521 Ottobrunn, Germany<br />
Thomas Kessler, Conference Manager<br />
Tel.: +49-89-189454-222<br />
E-Mail: kessler@eracon.org<br />
www.eRA2011.org<br />
Fee<br />
Regular: EUR 1,300<br />
Early Bird (available until 25 February): EUR 1,150<br />
(+ VAT, including conference bag and materials,<br />
certificate, lunch and coffee & tea breaks, diner on<br />
day 1)<br />
Confirmation<br />
Register early. Since space is limited please await the<br />
written confirmation of your registration.<br />
Cancelation<br />
Your notice of cancellation must be received in writing<br />
(letter or fax) 10 working days before the conference<br />
in order to transfer your event pass to someone else<br />
in the waiting list. We will be pleased to transfer your<br />
registration to another member of your company at<br />
any time. No cancellations will be accepted after that<br />
date.<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
6
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