Agenda eRA 2017

Day 1 - 10 May

08:30 Registration

A1 Keynotes

09:00 Opening eRA 2017 - Martin Schmid and Maximilian Munte, EXTEDO

09:15 eCTD Initiatives in Asia - supported by EXTEDO - Michael Zhang, Pfizer (China) R&D Center and Dr. Silke Nolkemper, EXTEDO

10:00 IDMP from an Industry and Agency Perspective - Vada Perkins, Identifica and Christian Kravogel, EXTEDO

10:30 Coffee break

11:00 Impact of ISO IDMP/SPOR on Regulatory - Remco Munnik, ASPHALION

11:30 World Class RIM Survey Debrief - Steve Gens, Gens and Associates

12:15 Fusion of eCTD and IDMP:  Evolution of a new species in the world of Regulatory Information Management - Anjana Pindoria, EXTEDO

12:30 Lunch break

Breakout Sessions

A2 Latest Innovations and Trends in eSubmissions

14:00 eSubmissions Roadmap - Karin Gröndahl, Medical Products Agency Sweden

14:30 eCTD 4.0/Next Major Version – Perspectives, Challenges and Oddities - Karl-Heinz Loebel, Pharmalex

15:00 How to convert your NeeS application into a consolidated eCTD baseline submission - Maren Müller, EXTEDO

B2 Latest Innovations and Trends in Drug Safety

14:00 The new Eudravigilance System – what’s coming in 2017 - Dr. Leonardo Ebeling,  Dr. Ebeling & Assoc.

14:30 New reporting obligations and other challenges from an industry perspective - Kieran O’Donnell, TMC Pharma

15:00 Case Study: Ludwig automated Safety Case Processing to PcVmanager in clinical trials - Sean Neal, Medidata Solutions

15:30 Coffee break

A3 Next Generation Planning & Tracking and Registration Management

16:00 Anatomy of RIMs - How can we maintain our Unique Identity in a world forcing us to be the same? – Anjana Pindoria, EXTEDO

16:30 IDMP Now! Get started with data collection and maintenance - Working with IDMP PREcollector and MPDmanager  - Christian Kravogel, EXTEDO and Alexander Beck, EXTEDO

17:00 Kern Pharma - A holistic approach to Regulatory Information Management - Cristina Luna Albalate, Kern and Remco Munnik, ASPHALION

B3 Regulatory Challenges and News in the US, Emerging Markets and the GCC Region

16:00 eCTD Initiatives in the US and Latin America - supported by EXTEDO - William Gardner-Mims, EXTEDO and Christine Hirt, EXTEDO

16:30 Challenges for Chinese API Producers - Customer Success Story - Qingling Lian, Qilu Antibiotics (Linyi) Pharmaceutical

17:00 GCC (Gulf Cooperation Council) Regulatory Update - Sophia Vraka, EXTEDO

C3 Regulatory Challenges in the CIS Region (in Russian langauge)

16.00 Bridging East and West as a key for new boundaries in Regulatory Affairs and Pharmacovigilance in CIS countries - Dr. Polina Furmane, Rephine Balticum, EXTEDO partner in CIS & Baltics

16.15 Increasing Efficiency and Transparency with eCTD - Expert from Lithuanian Health Authority

16.35 Challenges in legislation implementation in Regulatory and Pharmacovigilance on union level - Expert from Eurasian Union Commission on Pharmaceutical legislation

16.55 Sharing customer experience with eCTD implementation - Anna Popryshko, Arterium Corporation (Ukraine)

17.15 Moving from paper to electronics in the 21st century - Schei Dattner, sales4u (certified EXTEDO partner) and Christian Bohrmann, EXTEDO

17:30 End of official part day 1

18:30 Evening event and dinner at beach club - meet in hotel lobby for bus shuttle (included in all passes)