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Please note that LORENZ reserves the right to modify the agenda and/or list of speakers.

Contact LORENZ: www.lorenz.cc/email - Tel. +49 69 78991-150

LORENZ userBridge Agenda Highlights 18 - 20 September 2018, Prague, Czech Republic

Panel Discussion: eCTA - Europe• Dr. Andreas Franken, German Medicines Manufacturers’ Association

• Dr. Barbara Gansewendt, Bayer

• Dr. med. Klaus Menges, Federal Institute for Drugs and Medical Devices

• Harald von Aschen, Federal Institute for Drugs and Medical Devices

Table Tutorials• Safety Reporting to FDA, Dr. Veronika Alt und Dr. Sandra Oetjen, ERA Consulting

• Cross Application Linking - FDA, Freddy Day-Robinson, ICON Clinical Research

• Agency Round Table Q&A Session, Kent Briggs, VECTOR Life Sciences

• PSUR Repository Used Cases, Anna Rubik, ARAC

• eCTD Submissions in EU, Karl-Heinz Loebel, PharmaLex

• The metamorphoses of the South African Regulator: Changing from the Medicines Control Council (MCC) to the South

African Health Products Regulatory Authority (SAHPRA), Henriette Vienings, MRA Regulatory Consultants

• eCTD Progress and best practice in South Africa, Mia de Witt, Medfour

• Getting Documents Submission Ready, Martha Estruch, InvoFarma

• LORENZ docuBridge: Hyperlinking, Tim Ivanić, LORENZ

• eCTD version 4.0, Jared Lantzy, LORENZ

Presentations• Update on EMA/HMA developments, Remco Munnik, Asphalion

• EU Clinical Trial Portal and Database, Harald von Aschen, Federal Institute for Drugs and Medical Devices

• CESP Application Dataset Module - Implementation of IDMP using SPOR?, Dr. med. Klaus Menges, Federal Institute

for Drugs and Medical Devices

• Implications of Brexit for Regulatory Affairs, Dr. Sir Alasdair Breckenridge, Former Chair of the Medicines and

Healthcare Products Regulatory Agency (MHRA)

• EU Policy 0070 submissions today and in the future, Helle Ainsworth, Novo Nordsik

• Challenges in Supporting Submissions in Asia Pacific, Philipp Hall, AbbVie

• Submission Migration – A Challenging and Learning Experience, Luka Kovacic, Sandoz

• eCTD Digital View, Steven Tan & Dr. Ulrike Vollmer, Bayer

• Achieve business goals with transparent compliance, Klavs Esbjerg, Epista Life Science

• RIM – a single system or a happy family?, James Kelleher, Generis

• RIM implementation and integration, tailoring the evaluation for the right solution, Amara Tonkiss, Accenture

Conference Schedule

Day 1 - 18 September Day 2 - 19 September Day 3 - 20 September

08:00 - 09:00 Registration

08:30 - 12:15 Table Tutorials 08:30 - 12:15 Presentations09:00 - 12:15 Presentations

12:15 - 12:30 Closing Remarks

13:30 - 16:45 Presentations

13:30 - 15:15 Presentations

15:45 - 16:45 Panel Discussion

Conference Location Hotel Ambassador, Prague