22nd Annual Meeting of GQMA

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1 The 22nd International Meeting took place September 21st - 22nd, Maritim Hotel, Würzburg, Germany Access to our delegate handbook. German Society for Good Research Practice (DGGF e.v.) Page 1 of 11

2 Programme Wednesday, September 20, :00 AM - 5:30 PM Preconference Training Die Teilnehmerzahl ist begrenzt! Auf dem Anmeldeformular ist eine separate Anmeldung erforderlich. 9:00 AM - 3:30 PM GLP für Einsteiger Harston, Stephen; Ehrenpräsident der GQMA, Germany 9:00 AM - 5:30 PM Kommunikationsstrategien im Audit Meyer, Monika; AuditDialogConcept, Germany 6:00 PM Conference registration Thursday, September 21, :00 AM - 11:00 AM Plenary Session GxP_1 Chairs: König, Steffen; GQMA, Berlin, Germany 9:00 AM - 9:15 AM Opening address König, Steffen, GQMA President 9:15 AM - 10:30 AM We dice a study Christensen, Björn; University of Applied Science, Kiel, Germany 10:30 AM - 11:00 AM Break 11:00 AM - 12:30 PM Plenary Session GxP_2 - Data Integrity Basics Chair: Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany 11:00 AM - 11:45 AM The OECD Advisory Doc. No. 17 Advantages, Disadvantages and Challenges Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany 11:45 AM - 12:30 PM Moving From Big Data to Big Analysis Little, Eric; Osthus, Melbourne, USA 12:30 PM - 2:00 PM Lunch 2:00 PM - 4:00 PM Session: Analytics_1 Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany 2:00 PM - 2:45 PM Compliant E-Data Retention, Integration and Collaboration for LC/MS-MS Data using the AnIML Standard Schäfer, Burkhard; BSSN Software GmbH; Darmstadt, Germany 2:45 PM - 3:30 PM GLP for Sponsors why and how? Fröhlke, Erinita; GLP-Consulting; Münster, Germany German Society for Good Research Practice (DGGF e.v.) Page 2 of 11

3 Programme 3:30 PM - 4:00 PM Break 4:00 PM - 4:45 PM Session: Good Laboratory Practice_1 Chair: Hermann, Frauke; Envigo CRS GmbH, Rossdorf, Germany 4:00 PM - 4:45 PM Update on 21 part 58 draft GLP. Main proposed changes and their possible impact. Grande, Alessandra; Merck Biopharma, Turin, Italy 2:00 PM - 4:00 PM Session: Risk Management_1 Chair: Pillwein, Marion; Merck KGaA, Darmstadt, Germany 2:00 PM - 2:45 PM ISO 9001:2015 within clinical trial management an approach for risk based quality management Schaaf, Stefan; Q-FINITY, Dillingen, Germany 2:45 PM - 3:30 PM Practical Examples for Risk Management König, Steffen; IST GmbH; Mannheim, Germany 3:30 PM - 4:00 PM Break 4:00 PM - 5:30 PM Session: Good Vigilance Practice_1 Chair: Scholz, Bianca; ScholzPharma GmbH, Bensheim, Germany 4:00 PM - 4:45 PM E2B R3 Implementation and associated requirements Alesik, Eva; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany 4:45 PM - 5:30 PM Risk Based Audit Program - the Art of Selecting the Right Targets. Weber, Melanie; Pietrek Associates, Weinheim, Germany 2:00 PM - 4:00 PM Session: Good Distribution Practice_1 Chair: Niggemann, Björn; ELPRO-BUCHS AG, Buchs, SG, Switzerland 2:00 PM - 2:45 PM Just paying attention to certificates means: missing the essentials! - Qualification of forwarders, carriers, and subcontractors. Specht, Christian; EIPL European Institute for Pharma Logistics GmbH, Korntal-Münchingen (Stuttgart), Germany 2:45 PM - 3:30 PM The last mile of drug supply in clinical trials Behrend, Bardo; Nextpharma, Göttingen 3:30 PM - 4:00 PM Break 4:00 PM - 5:30 PM Session: Good Manufacturing Practice_1 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland German Society for Good Research Practice (DGGF e.v.) Page 3 of 11

4 Programme 4:00 PM - 4:45 PM Finding the Path to Data Integrity in agmp environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany 4:45 PM - 5:30 PM Continuation: Finding the Path to Data Integrity in agmp environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany Friday, September 22, :00 AM - 11:00 AM Session: Good Laboratory Practice_2 Chair: Neuss, Jürgen; Bayer AG, Frankfurt, Germany 9:00 AM - 9:45 AM Laboratories are going Paperless : Electronic Raw Data Archiving in practice Schölzke, Brunhilde; Merck Sharpe & Dhome (MSD), Schwabenheim, Germany 9:45 AM - 10:30 AM Is our GLP system suitable for the challenges of recent developments? GLP News, especially focussing on New Techniques Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany 10:30 AM - 11:00 AM Break 11:00 AM - 12:30 PM Session: Good Laboratory Practice_3 Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany 11:00 AM - 11:45 AM GLP Round Table Discussion Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany Uhde, Holger; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany 11:45 AM - 12:30 PM GLP Round Table Discussion (continued) 9:00 AM - 11:00 AM Session: Good Clinical Practice_1 Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany 9:00 AM - 9:45 AM Electronic Informed Consent Stanbrook, Rebecca; Novartis, Basel, Switzerland 9:45 AM - 10:30 AM Archiving of eclinical Systems and Data Summa, Wolfgang; Merck, Darmstadt, Germany 10:30 AM - 11:00 AM Break German Society for Good Research Practice (DGGF e.v.) Page 4 of 11

5 Programme 11:00 AM - 12:30 PM Session: Good Clinical Practice_2 Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany 11:00 AM - 11:45 AM e-data - regulatory expectations Bregnhøj, Lisbeth and Ib Alstrup; Danish Medicine Agency, Copenhagen, Denmark 11:45 AM - 12:30 PM GCP round table Summa, Wolfgang; Merck, Darmstadt, Germany Bregnhøj, Lisbeth; Danish Medicine Agency, Copenhagen, Denmark Alstrup, Ib; Danish Medicine Agency, Copenhagen, Denmark 11:00 AM - 12:30 PM Session GxP_3 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland 11:00 AM - 11:45 AM Quality Management in the Digital Age Gaertner, Robert; Veeva Systems, Hofheim, Germany 11:45 AM - 12:30 PM Roll out and implementation of a globally harmonized eqms Jachmann, Verena; Fresenius Kabi Deutschland GmbH, Oberursel; Germany Schmidt, Sabine; MAIN5 GmbH, Frankfurt, Germany 12:30 PM - 2:00 PM Lunch 2:00 PM - 3:00 PM Plenary Session GxP_4 Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany 2:00 PM - 2:45 PM Patient Centricity: How to successfully involve patients into clinical development Keiper, Tanja; Merck KGaA; Darmstadt, Germany 2:45 PM - 3:00 PM Closing Remarks König, Steffen; GQMA 3:00 PM - 3:15 PM Short Break 3:15 PM - 4:15 PM GQMA Members' Meeting Chairs: König, Steffen, GQMA German Society for Good Research Practice (DGGF e.v.) Page 5 of 11

6 Titles Archiving of eclinical Systems and Data Summa, Wolfgang; Merck, Darmstadt, Germany Friday, September 22, 2017, 9:45 AM - 10:30 AM Closing Remarks König, Steffen; GQMA Friday, September 22, 2017, 2:45 PM - 3:00 PM Compliant E-Data Retention, Integration and Collaboration for LC/MS-MS Data using the AnIML Standard Schäfer, Burkhard; BSSN Software GmbH; Darmstadt, Germany Continuation: Finding the Path to Data Integrity in agmp environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany Thursday, September 21, 2017, 4:45 PM - 5:30 PM E2B R3 Implementation and associated requirements Alesik, Eva; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany e-data - regulatory expectations Bregnhøj, Lisbeth and Ib Alstrup; Danish Medicine Agency, Copenhagen, Denmark Electronic Informed Consent Stanbrook, Rebecca; Novartis, Basel, Switzerland Friday, September 22, 2017, 9:00 AM - 9:45 AM Finding the Path to Data Integrity in agmp environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany GCP round table Summa, Wolfgang; Merck, Darmstadt, Germany Bregnhøj, Lisbeth; Danish Medicine Agency, Copenhagen, Denmark Alstrup, Ib; Danish Medicine Agency, Copenhagen, Denmark GLP for Sponsors why and how? Fröhlke, Erinita; GLP-Consulting; Münster, Germany GLP für Einsteiger Harston, Stephen; Ehrenpräsident der GQMA, Germany Wednesday, September 20, 2017, 9:00 AM - 3:30 PM German Society for Good Research Practice (DGGF e.v.) Page 6 of 11

7 Titles GLP Round Table Discussion Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany Uhde, Holger; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany GLP Round Table Discussion (continued) Is our GLP system suitable for the challenges of recent developments? GLP News, especially focussing on New Techniques Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany Friday, September 22, 2017, 9:45 AM - 10:30 AM ISO 9001:2015 within clinical trial management an approach for risk based quality management Schaaf, Stefan; Q-FINITY, Dillingen, Germany Just paying attention to certificates means: missing the essentials! - Qualification of forwarders, carriers, and subcontractors. Specht, Christian; EIPL European Institute for Pharma Logistics GmbH, Korntal-Münchingen (Stuttgart), Germany Kommunikationsstrategien im Audit Meyer, Monika; AuditDialogConcept, Germany Wednesday, September 20, 2017, 9:00 AM - 5:30 PM Laboratories are going Paperless : Electronic Raw Data Archiving in practice Schölzke, Brunhilde; Merck Sharpe & Dhome (MSD), Schwabenheim, Germany Friday, September 22, 2017, 9:00 AM - 9:45 AM Moving From Big Data to Big Analysis Little, Eric; Osthus, Melbourne, USA Thursday, September 21, 2017, 11:45 AM - 12:30 PM Patient Centricity: How to successfully involve patients into clinical development Keiper, Tanja; Merck KGaA; Darmstadt, Germany Friday, September 22, 2017, 2:00 PM - 2:45 PM Practical Examples for Risk Management König, Steffen; IST GmbH; Mannheim, Germany Quality Management in the Digital Age Gaertner, Robert; Veeva Systems, Hofheim, Germany Risk Based Audit Program - the Art of Selecting the Right Targets. Weber, Melanie; Pietrek Associates, Weinheim, Germany Thursday, September 21, 2017, 4:45 PM - 5:30 PM German Society for Good Research Practice (DGGF e.v.) Page 7 of 11

8 Titles Roll out and implementation of a globally harmonized eqms Jachmann, Verena; Fresenius Kabi Deutschland GmbH, Oberursel; Germany Schmidt, Sabine; MAIN5 GmbH, Frankfurt, Germany The last mile of drug supply in clinical trials Behrend, Bardo; Nextpharma, Göttingen The OECD Advisory Doc. No. 17 Advantages, Disadvantages and Challenges Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany Thursday, September 21, 2017, 11:00 AM - 11:45 AM Update on 21 part 58 draft GLP. Main proposed changes and their possible impact. Grande, Alessandra; Merck Biopharma, Turin, Italy We dice a study Christensen, Björn; University of Applied Science, Kiel, Germany Thursday, September 21, 2017, 9:15 AM - 10:30 AM German Society for Good Research Practice (DGGF e.v.) Page 8 of 11

9 Presenters Stanbrook, Rebecca; Novartis, Basel, Switzerland Electronic Informed Consent Friday, September 22, 2017, 9:00 AM - 9:45 AM Alesik, Eva; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany E2B R3 Implementation and associated requirements Alstrup, Ib; Danish Medicine Agency, Copenhagen, Denmark GCP round table Behrend, Bardo; Nextpharma, Göttingen The last mile of drug supply in clinical trials Bregnhøj, Lisbeth and Ib Alstrup; Danish Medicine Agency, Copenhagen, Denmark e-data - regulatory expectations Bregnhøj, Lisbeth; Danish Medicine Agency, Copenhagen, Denmark GCP round table Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany GLP Round Table Discussion Christensen, Björn; University of Applied Science, Kiel, Germany We dice a study Thursday, September 21, 2017, 9:15 AM - 10:30 AM Fröhlke, Erinita; GLP-Consulting; Münster, Germany GLP for Sponsors why and how? Gaertner, Robert; Veeva Systems, Hofheim, Germany Quality Management in the Digital Age Grande, Alessandra; Merck Biopharma, Turin, Italy Update on 21 part 58 draft GLP. Main proposed changes and their possible impact. Harston, Stephen; Ehrenpräsident der GQMA, Germany GLP für Einsteiger Wednesday, September 20, 2017, 9:00 AM - 3:30 PM German Society for Good Research Practice (DGGF e.v.) Page 9 of 11

10 Presenters Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany Continuation: Finding the Path to Data Integrity in agmp environment Thursday, September 21, 2017, 4:45 PM - 5:30 PM Finding the Path to Data Integrity in agmp environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Continuation: Finding the Path to Data Integrity in agmp environment Thursday, September 21, 2017, 4:45 PM - 5:30 PM Finding the Path to Data Integrity in agmp environment Jachmann, Verena; Fresenius Kabi Deutschland GmbH, Oberursel; Germany Roll out and implementation of a globally harmonized eqms Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany GLP Round Table Discussion Is our GLP system suitable for the challenges of recent developments? GLP News, especially focussing on New Techniques Friday, September 22, 2017, 9:45 AM - 10:30 AM Keiper, Tanja; Merck KGaA; Darmstadt, Germany Patient Centricity: How to successfully involve patients into clinical development Friday, September 22, 2017, 2:00 PM - 2:45 PM König, Steffen, GQMA President Opening address Thursday, September 21, 2017, 9:00 AM - 9:15 AM König, Steffen; GQMA Closing Remarks Friday, September 22, 2017, 2:45 PM - 3:00 PM König, Steffen; IST GmbH; Mannheim, Germany Practical Examples for Risk Management Little, Eric; Osthus, Melbourne, USA Moving From Big Data to Big Analysis Thursday, September 21, 2017, 11:45 AM - 12:30 PM Meyer, Monika; AuditDialogConcept, Germany Kommunikationsstrategien im Audit Wednesday, September 20, 2017, 9:00 AM - 5:30 PM German Society for Good Research Practice (DGGF e.v.) Page 10 of 11

11 Presenters Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany The OECD Advisory Doc. No. 17 Advantages, Disadvantages and Challenges Thursday, September 21, 2017, 11:00 AM - 11:45 AM Schaaf, Stefan; Q-FINITY, Dillingen, Germany ISO 9001:2015 within clinical trial management an approach for risk based quality management Schäfer, Burkhard; BSSN Software GmbH; Darmstadt, Germany Compliant E-Data Retention, Integration and Collaboration for LC/MS-MS Data using the AnIML Standard Schmidt, Sabine; MAIN5 GmbH, Frankfurt, Germany Roll out and implementation of a globally harmonized eqms Schölzke, Brunhilde; Merck Sharpe & Dhome (MSD), Schwabenheim, Germany Laboratories are going Paperless : Electronic Raw Data Archiving in practice Friday, September 22, 2017, 9:00 AM - 9:45 AM Specht, Christian; EIPL European Institute for Pharma Logistics GmbH, Korntal-Münchingen (Stuttgart), Germany Just paying attention to certificates means: missing the essentials! - Qualification of forwarders, carriers, and subcontractors. Summa, Wolfgang; Merck, Darmstadt, Germany Archiving of eclinical Systems and Data Friday, September 22, 2017, 9:45 AM - 10:30 AM GCP round table Uhde, Holger; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany GLP Round Table Discussion Weber, Melanie; Pietrek Associates, Weinheim, Germany Risk Based Audit Program - the Art of Selecting the Right Targets. Thursday, September 21, 2017, 4:45 PM - 5:30 PM German Society for Good Research Practice (DGGF e.v.) Page 11 of 11

23rd Annual Meeting of GQMA

23rd Annual Meeting of GQMA The 23 rd International Meeting 2018 took place September 20-21, Maritim Hotel, Bonn, Germany German Society for Good Research Practice (DGGF e.v.) Page 1 of 16 Programme Wednesday, September 19, 2018