OPENeCTD formerly - Extedo

OPENeCTD formerly - Extedo



eRegulatory Affairs 2011

Get ready for the new ERA of electronic regulatory communications!


13 – 14 April 2011

BlueBay Galatzo Hotel, Peguera, Majorca, Spain



About the eRA (formerly OPENeCTD forum)

A new name, but still essential: In 2011 we move beyond the

usual eCTD topics and add other eRegulatory Affairs topics

such as drug safety, labeling, registration management and

document management. Due to our global presence we

have also organized an additional event in North America


The eRA2011 conference provides an ideal knowledge

sharing opportunity, with a history of presenting key

eRegulatory developments and the latest news around

the eSubmis sion & Labeling standards by a distinguished

panel of industry and authority speakers.

The eRA2011 is organized in three specialized tracks

covered by more than 30 domain experts.

Gain valuable insights for your organization by learning

about new eRegulatory developments and standards and

case studies.

Engage representatives from a variety of different

organizations (industry & authority) in a stimulating and

open environment about issues critical to your business.

Get ready for the new ERA of electronic regulatory


Who should participate?

eRA 2011 will particularly benefit professionals who work

in Pharmaceutical Drug Regulatory Affairs or Dossier

Assessment and Registration offices – directors and

experts of regulatory affairs and dossier review, as well

as IT managers focused on introducing IT systems for

pharmaceutical regulatory processes. Experts who are

involved in the compilation, publishing and reviewing of

regulatory submissions will also benefit by attending.

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT




Agenda: Wednesday, 13 April 2011 – Day 1

08:00 – 09:30

09:30 – 09:45

09:45 – 10:15

10:15 – 10:45

• Registration

• Opening eRA2011 – Tore Bergsteiner & Martin Schmid

• Electronic Submissions in Europe – EMAs Roadmap and Vision – Hans Georg Wagner (European Medicines Agency)

• eSubmission: The Good, The Bad, The Future – Michael Schaub (Regulatory Pharma Net)

10:45 – 11:15 Coffee Break

11:15 – 12:00

12:00 – 12:30

• Your eRegulatory World – Winds of Change – Steve Scribner (International Life Science Solutions)

• Current Status of Electronic Regulatory Affairs Standards in Europe – Vito Strasberger (Nanokinetik)

12:30 – 14:00 Lunch – sponsored by ProductLife

14:00 – 15:30 A1 Submission Planning & Tracking – How to manage


• B.Braun´s View on an Integrated Regulatory

Application Landscape and How to Get There –

Harald Weis (B.Braun)

• Swissmedic‘s Submission Tracking and Reviewing

Now and in the Future – What is in it for the

Applicants? – Susanne Kienberger (Swiss Authority,


• Submission Planning & Tracking of Agency

Communication – Ruedi Blattmann (Life Science

Consulting Partners, LSCP)


EU-Regulation & Validation

• Validation of eCTD and NeeS – An Industry

Perspective – Alastair Nixon (GSK)

• The Improved Validation Criteria – Karin Gröhndal

(Swedish Authority, MPA)

• e-Submission Validation in Europe – Balancing National

Agencies‘ Requirements with an Applicants‘

Desire for a Harmonized Dossier – Karl-Heinz

Loebel (Pharmalex)


Sponsoring Partner Track

• Managing Electronic Submission Documents and

Correspondence – Cyril Walsh (QUMAS)

• From Paper-Dossier to eCTD – Andreas Treptow

(Optimal Systems)

15:30 – 16:00 Coffee Break

16:00 – 17:30 A2 Customer Success Stories


Worldwide Standards and Interoperability


Sponsoring Partner Track

• How to Replace Three Legacy eSubmission

Systems with a New One – Adam Aparicio (Merck)

• Global eSubmission management – act local and

and think global – the Angelini Group experience –

Maria Angela Gatto (Angelini)

• CanReg’s eCTD Success Story and Lessons

Learned – Ted Hanebach (CanReg)

• Introduction to the IRISS Forum (Implementation

of Regulatory Information Submission Standards) –

Deanna Murden (ePharmaCMC, LLC)

• An Update on the IRISS ETICS III Project: The EU

Arm of the Study – John-Paul Smith (Celgene)

• Electronic Submissions in the Far East –

Harv Martens (EXTEDO)

• Sharepoint Validation Services – Klavs Esbjerg

(Epista IT)

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT




Agenda: Thursday, 14 April 2011 – Day 2

09:00 – 10:30 A3 Communicating with the Authorities (EiY User

Group Meeting – Open Part)

• How the Quality of Received Submissions Influences

the Review Process at NCAs – Mickel

Hedemand (Danish Authority, DKMA)

• eSubmission in MRP/DCP – a Field Report.

Discussion with the Audience – Petra Grundhöfer



Core-Dossier Management

• Master – Dossier Management carried to the

Extreme: Every Dossier needs a Master – Dr. Peter

Rossmanith (BASF)

• Planning Successful Multi-country electronic Submissions

– Hans van Bruggen, eCTDconsultancy

• The eCTD Experience at Synthon – Ellen Simons



Pharmacovigilance in a new ERA

• Recent Changes in US Regulations Regarding

Clinical Trial IND – Jim Buchanan (BioSoteria)

• Risk Management and the Future of Pharmacovigilance

– Dr. Erick Gaussens (ProductLife)

• Audits and Inspections in Pharmacovigilance –

Focus on Electronic Systems – Dr. Reinhard Nibler

(Dr. Nibler & Partner)

10:30 – 11:00 Coffee Break

11:00 – 12:30 A4 Regulatory Compliance Leveraging Outsourcing

and Hosting Services

• Case Study: Outsourcing from a Service Provider’s

Perspective – Katrin Spaepen (Comply Services)

• Using PcVmanager in a Hosted Environment –

Prof. Dr. Paolo Biffignandi (Euvigilance)

• An Efficient Platform for Drug Safety Management

– EXTEDO’s Software as a Service –

Prof. Dr. Tho mas Städter (EXTEDO)


Structured Product Information

• Structured Product Information with DITA – a well

established XML standard since 2004 – Christian

Kravogel (EXTEDO)

• The US-Standard SPL – a solution for Europe too?

Karl-Heinz Loebel (Pharmalex)

• Podium Discussion: PIM / Structured Product

Information – The ugly truth – Karl-Heinz Loebel

(Pharmalex), Dr. Jaroslava Paraškevová (MEDA

Pharma), Christian Kravogel (EXTEDO)


EiY User Group Meeting – Authorities only

• Introduction of EURS is Yours and First Reviewing

Experiences – Eduardas Sizovas (Lithuanian


• Agency perspective on validation – Pieter

Vankeerberghen (FAGG)

• ICI and EiY make it easy – Dr. Ricco van den Hoorn


12:30 – 13:00 Open Discussion between Industry and Agency Closing Remarks

13:00 – 14:00 Lunch

14:00 – 15:30 A5 eCTDmanager User Group Meeting


PcVmanager User Group Meeting


EiY User Group Meeting – Authorities only

• New Features

• Roadmap

• Wishlist (open discussion)

• New Features

• Roadmap

• Wishlist (open discussion)

• New Features

• Roadmap

• Wishlist (open discussion)

15:30 Final Conference Closing with Drinks and Snacks

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT




eRA Initiator Gold Sponsor Silver Sponsors Bronze Sponsor Individual Sponsor

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT






BlueBay Galatzo Hotel

Carretera de Palma a Andratx, km 20

07160 Paguera – Calvià, Islas Baleares, Spain

Phone +34 971 68 96 00


The BlueBay Galatzo Hotel has allocated a block of bedrooms at a special

rate for attendees:

Single room: EUR 105 / Double room: EUR 125 (per night)

Please use this opportunity. Reservations have to be done via e-mail or fax

with the specific hotel reservation form, available online:

–> Registration


Please register online: –> Registration


eRA2011 Conference


Einsteinstrasse 30

85521 Ottobrunn, Germany

Thomas Kessler, Conference Manager

Tel.: +49-89-189454-222



Regular: EUR 1,300

Early Bird (available until 25 February): EUR 1,150

(+ VAT, including conference bag and materials,

certificate, lunch and coffee & tea breaks, diner on

day 1)


Register early. Since space is limited please await the

written confirmation of your registration.


Your notice of cancellation must be received in writing

(letter or fax) 10 working days before the conference

in order to transfer your event pass to someone else

in the waiting list. We will be pleased to transfer your

registration to another member of your company at

any time. No cancellations will be accepted after that


eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT


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