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2nd Annual

GENOTOXIC IMPURITIESin PHARMACEUTICALSSUMMIT2020

◆ 10+ Program Hours | 8+ Networking Hours◆ Refreshments & Coffee Breaks◆ Business Lunches & Dinner ◆ Case Studies | Workshops◆ Panel Discussions | Q & A

November 19-20 | Prague, Czech Republic

Raphael Nudelman, Ph.D., ERT Director, Chemical & Computational ToxicologyTeva Pharmaceutical Industries Ltd., IL

Dr. Lutz MüllerToxicology Project Leader – Distinguished ScientistF. Hoffmann-La Roche Ltd., CH

Lance Smallshaw BSc(Hons) PhD EurChem CSci CChem FRSCRegulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia)UCB Biopharma sprl., BE

Dr. Jacques Van Gompel PhDEU Head Genetic ToxicologyJanssen Pharmaceutica NV, BE

Mark HarrisonPrincipal AnalystAstraZeneca, UK

Carla Landolfi, ERTEuropean Registered Toxicologist (ERT) R&D, Head of WEP Toxicology - Preclinical DevelopmentAngelini, IT

Mike Urquhart Scientific DirectorGlaxoSmithKline, UK

WHO YOU WILL MEET

INDUSTRIES◆ Pharmaceutical◆ Biotechnology◆ Chemical◆ Medical Devices◆ Plastics

INDUSTRIES◆ CMOs/CDMOs◆ CROs ◆ NOPs◆ Regulatory Agencies◆ Training providers◆ Other

POSITIONS◆ C-Level, Presidents, Chairs, Members of the Board & VPs◆ Vice presidents, Directors, & Heads◆ Leaders & Managers◆ Principals, Fellows & Scientists◆ Toxicologists & Chemists◆ Advisors, Coordinators, Auditors & Consultants◆ Other Professionals, Experts & Specialists

🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]

SNAPSHOT OF ATTENDEES - Highly Potent APIs Summit 2019:- Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - OthersAgenda: https://qepler.com/pdf/hpapi.pdf

SNAPSHOT OF ATTENDEES - Genotoxic Impurities in Pharmaceuticals Summit 2019:Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - OthersAgenda: https://qepler.com/pdf/genetoxic.pdf

SNAPSHOT OF ATTENDEES - Drug/Device Combination Products Summit 2018:AbbVie - Ablynx - anteris medical - AOP Orphan Pharmaceuticals - Astellas Pharma - AstraZeneca - BIOCORP - Biogen - Boehringer Ingelheim microParts - Bristol-Myers Squibb - BSI Group - Corvus Device - Cytel - Design Science - Eli Lilly - Freelancer - GSK - H&B Electronic - H&T Presspart - Hanway Associates - Janssen - LEO Pharma - Maetrics - Medac - Medtronic - Nelson Labs - Nelson Labs Europe - Novartis - Orion Corporation - Orion Pharma - Pall Life Sciences - Pharmathen - Progress - PME - Regeneron Pharmaceuticals - Sanofi R&D - Sanofi-Aventis - sfm medical devices - Sharp Clinical Services - Spiegelberg - TERUMO EUROPE - tesa Labtec - Teva - UPM Raflatac - OthersAgenda: https://qepler.com/pdf/ddc.pdf

DIVISIONS◆ Pharmacology◆ Pharmacovigilance◆ Process Chemistry◆ Process Development◆ QbD◆ Quality Assurance & Operations◆ Quality Control◆ Regulatory Affairs & Compliance◆ Research & Development◆ Risks Assessment◆ Small Molecules◆ Toxicology◆ Toxicology Discovery◆ Validation◆ Other

◆ Drug Development◆ Drug Safety◆ Drug Safety Research & Evaluation◆ Genetic Toxicology◆ Genetics & Mutagenesis◆ Genotoxicity◆ GMP◆ GTIs◆ Impurities◆ In Silico Toxicology◆ Metabolism◆ Mutagenicity◆ Pharmaceutical Sciences◆ Pharmacokinetics

◆ ADME◆ Analytical Chemistry◆ Analytical Development◆ Analytical R&D◆ Analytical Science◆ Analytical Science & Technology◆ Analytical Sciences◆ API◆ Biocompatibility◆ Chemical Toxicology◆ CMC◆ Compound Safety◆ Computational Toxicology◆ Data Sciences & Artificial Intelligence

https://qepler.com/pdf/hpapi.pdf

https://qepler.com/pdf/genetoxic.pdf

https://qepler.com/pdf/ddc.pdf

http://qepler.com/pdf/lyo.pdf

GENOTOXIC IMPURITIESin PHARMACEUTICALS

SUMMIT2020


Regulatory guidelines on genotoxic impurities and strategies.Regulatory updates for the control and analysis of GTIs.

Practical implementation of ICH M7 and ICH Q3D. Regulatory submission guidance.ICH M7(R1) and (R2) additions and compliance. ICH guidelines and extractables & leachables.

Genotoxic risk evaluation - preclinical perspective:Genotoxic risk evaluation. In Vitro genotoxicity testing for alerting GTIs qualification.Genotoxic risk evaluation. In Vivo genotoxicity testing for alerting GTIs qualification.

DNA binding assays for alerting GTIs qualification.Evaluating GTIs potential through structure activity relationship.

Compound risks assessment for GTIs.Genotoxic metabolites identification and risk management.

Genotoxic thresholds identification.Perspective GTIs risks identifications.

GTIs risks evaluation.Strategies for GTIs analysis.

Identifying API degradants potential for genotoxicity.Genotoxicity and carcinogenicity alerts.

Acceptable exposure limits for impurities and compounds from carcinogenic perspective. Evaluation of genotoxic impurities through In silico assessment.

In silico prediction systems. In silico assessment. Risks reduction through use of predictive tools.

Preclinical assessment of GTIs. Regulatory updates, assays, data interpretation.Compounds purification for early toxicology profiling.

GTIs analysis through gas chromatography.GTIs quantification in APIs.

Analytical testing and control approaches for GTIs in drug substance.Genotoxic degradation products identification and control.

Compound specific risk assessment - acceptable levels identification.Calculating compound specific exposure limits.

Potential impurities identification - safety assessment from EL.GTIs risk assessment through genotoxicity screening assay.

GTI testing at all stages of drug development.Genotoxic risk assessments and the purge factor methodology.

Big Data use to improve GTIs predictions: computational methods for a better mutagenicity.Analytical methods and techniques to monitor potential GTIs.

Analytical control for genotoxic impurities.Implementing QbD approach into genotoxic impurities control.Purge tools application to improve mutagen control strategies.


PROPOSED TOPICS


SUMMIT2020

November 19 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee

08:30 - 08:40 🎤 Opening Address from the Chairman

09:20 - 10:00 🤝 Speed Networking

08:40 - 09:20

10:00 - 10:40

11:10 - 12:10

12:10 - 12:50

Case Study 1 - TBA

Dr. Lutz Müller | Toxicology Project Leader – Distinguished Scientist | F. Hoffmann-La Roche Ltd., CH

10:40 - 11:10 🍵 Morning coffee and networking break

12:50 - 13:50 🍽 Business lunch


13:50 - 14:20

ICH M7 : Case studies and reflections

Dr. Jacques Van Gompel PhD | EU Head Genetic Toxicology | Janssen Pharmaceutica NV, BE

Workshop 1

Case Study 3 - TBA

Lance Smallshaw BSc(Hons) PhD EurChem CSci CChem FRSC | Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia) | UCB Biopharma sprl., BE

Slot Reserved for a Gold or Silver Sponsor


SUMMIT2020

November 19 | Prague, Czech Republic

15:00 - 15:30 🍵 Afternoon coffee and networking break

18:10 - 18:20 🎤 Chairman’s closing remarks and end of day one

19:00 - 21:00 🥂 Business dinner

14:20 - 15:00

15:30 - 15:50

15:50 - 16:30

16:30 -17:10

17:10 -18:00 💡 Roundtable Discussion


TBA

Carla Landolfi, ERT | European Registered Toxicologist (ERT) R&D, Head of WEP Toxicology - Preclinical Development | Angelini, IT

Slot Reserved for a Booth or Bronze Sponsor

Case Study 5

Case Study 5 - TBA

Mark Harrison | Principal Analyst | AstraZeneca, UK

Topics


SUMMIT2020

November 20 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee

08:30 - 08:40 🎤 Opening Address from the Chairman

08:40 - 09:20

10:30 - 10:50

09:20 - 10:00


10:00 - 10:30 🍵 Morning coffee and networking break

10:50 - 12:10

TBA

Mike Urquhart | Scientific Director | GlaxoSmithKline, UK

Slot Reserved for a Speaking Sponsor

Workshop 2

12:10 - 13:10 🍽 Business lunch

13:10 - 13:30 Slot Reserved for a Speaking Sponsor

Case Study 1 - TBA

Raphael Nudelman, Ph.D., ERT | Director, Chemical & Computational Toxicology | Teva Pharmaceutical Industries Ltd., IL


SUMMIT2020

November 20 | Prague, Czech Republic

14:10 - 14:40 🍵 Afternoon coffee and networking break

16:20 -16:30 🎤 Chairman’s closing remarks and end of day two

15:20 - 16:00

14:40 - 15:20

13:30 -14:10 Case Study 2

Case Study 3

Case Study 4

16:00 - 16:20 💡 Q & A



SUMMIT2020


BIOGRAPHIES


Raphael Nudelman, Ph.D., ERT Director, Chemical & Computational ToxicologyTeva Pharmaceutical Industries Ltd., IL

Raphael completed his Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, followed by postdoctoral positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland USA and in Duke University Medical Center, North Carolina USA. He joined Teva Pharmaceutical Industries’ Medicinal Chemistry department in 2003 and in 2010 he established the Chemical & Computational Toxicology group which he currently heads. Raphael is a member of the American Chemical Society (ACS), the American Association of Pharmaceutical Scientists (AAPS), and of the Israel Chemical Society (ICS). From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). He is a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education and a member of the Advisory Editorial Boards of Elsevier’s journal Drug Discovery Today: Technologies, and of Trends in Medicine and Health (TMH).

Dr. Lutz MüllerToxicology Project Leader – Distinguished ScientistF. Hoffmann-La Roche Ltd., CH

I am a biologist with a Ph.D. in genetics as of 1986 and supplemental qualifications in EUDIPHARM and PharmaTrain in the EU. I started my professional career in the German Federal Health Office in 1986 as a reviewer in the Department of Pharmacology and Toxicology at the Institute for Drugs in Berlin, Germany. In 1989, I was appointed Head of the Section on Mutagenicity and Carcinogenicity in the German Federal Institute for Drugs and MedicalDevices. In leading this section, I translated the results of experimental research activities of the section on mechanisms of action in these areas into the risk/benefit assessment and approval process of new pharmaceuticals on the national and EU level. The section included an active experimental safety research group that was supported by various German and EU research grants. On the international level, I was appointed to serve as an expert toxicologist to the Safety Working Party of the EU CHMP and became ICH Rapporteur for the ICH guidelines on genotoxicity in 1992. These guidelines were successfully finalized and came into operation in 1995 and 1997.In June 2000, I joined the global Preclinical Safety Organization of Novartis Pharma AG in Basel, Switzerland. At Novartis I supported the research and development process within Preclinical Safety (PCS) towards an optimized screening and selection strategy as global expert in Experimental and Molecular Toxicology and subsequently as Head of Investigational and in silico Safety & Metabolism. In addition, in my role as an international project team representative, I contributed to safety testing, evaluation and regulatory documentation for several projects in oncology. As globally responsible advisor for drug quality, I supported the Novartis technical organization for drug quality processes.In November 2004, I joined the Pharmaceutical Sciences organization of F. Hoffmann-La Roche in Basel as Toxicology Project Leader. Since then, I have led the toxicology program for various projects in immunology, inflammation, virology, cardiovascular & metabolic, CNS and rare diseases involving small molecules and biologics. Currently, I have responsibility for oversight on non-clinical safety for projects in early and advanced stages of pre-clinical, clinical development and selected marketed drugs. Projects with my contribution have passed successfully reviews by Health Authorities in all ICH regions (US, Europe and Japan) as well as in other countries such as China in all stages of preclinical, clinical development, approval for marketing and post-approval reviews. Since 2006, I represent the European Pharmaceutical industry in the ICH process for ICH safety guidelines, including the revision of ICH S2 (genotoxicity testing) and ICH M7 (Mutagenic and Carcinogenic Impurities). Within F. Hoffmann-La Roche, I serve on the Non-Clinical Drug Safety Governance body and chair the Carcinogenicity Strategy Advisory Board. I am the liaison for the neuroscience, ophthalmology and rare diseases therapeutic areas in Roche Pharma Research and Early Development (pRED) and for the non-clinical/clinical translation into clinicaldevelopment.My contributions to research on and guidance for toxicity testing and assessment thereof for pharmaceuticals have resulted so far in more than 100 original publications, monographs and book chapters. I have frequently organized and lectured on international conferences in toxicology and R&D in drug development.


SUMMIT2020


BIOGRAPHIES


Lance Smallshaw BSc(Hons) PhD EurChem CSci CChem FRSCRegulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia)UCB Biopharma sprl., BE

After completing nearly a total of 38 years at Eli Lilly and Company and UCB Biopharma sprl based in various international locations he has specialised in both biopharmaceutical / chemical analytical development and GMP QC. Lance has been associated with numerous UK government new analytical technologies projects from routine testing to PAT and was a trainer in Statistical Process Control (SPC) for more than 15 years. He was one of the original conception members of the European CMC Committee for CaSSS in Biopharmaceuticals. He has more than a decades experience as trainer in Good Quality Control Laboratory Practice and in the associated Chapters / Annexes of the European GMP Guide for the European Qualified Person Association (EQPA) and in 2013 Lance was appointed to the Foundation Board of the European Compliance Acacdemy (ECA) and is currently their Co-Chairman. In the past six years Lance has led the UCB Global team to define the strategy and to revise the compendial heavy metals test following ICH’s announcement to update the test using a risk based approach with the introduction of its Guideline on Elemental Impurities (ICH Q3D). Lance is currently based in Belgium working in the UCB Corporate Analytical Sciences (CAS) team as Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia).

Dr. Jacques Van Gompel PhDEU Head Genetic ToxicologyJanssen Pharmaceutica NV, BE

After studies in Cell Biology & Genetics at the Free University of Brussels (1987), Jacques Van Gompel was appointed a position as research assistant within the dept. of Experimental Pathology at the University Hospital (AZ-VUB). There, he performed research on the morphology, genetics and immunology of Diabetes mellitus type I. There after he joined the Janssen Research Foundation in 1992. Until February 2000 he was Study Director for the bacterial and mammalian gene mutation assays within the dept. of Genetic and in vitro Toxicology. Meanwhile he also obtained his PhD at the Free University of Brussels on the topic of “Development, Evaluation and Implementation of Acute and Chronic in vitro Exposure Methods in Applied Genetic Toxicology”. Between 1995 and 2000 he successfully completed two European Community funded projects in the area of hepatotoxicity and perfusion culture. From February 2000 until April 2001 he became responsible for the genetic toxicology profiling within the newly formed dept. of Exploratory Development. Since May 2001 he became group leader within the ADME/TOX dept. of Johnson&Johnson Pharmaceutical Research & Development. Next to the functional responsibility for the genotoxicity screening activities, he is ADME/TOX representative for discovery projects in the areas of CNS, Oncology and HIV from Hit-to-Lead until delivery into the Preclinical Development Organization. In June 2005 he became Head of the dept of Genetic and in vitro Toxicology within the Global PreClinical Development organization. Furthermore the dept. has end-to-end responsibilities within Janssen Pharmaceutica from Hit-to-Lead until brand support and for high throughput genotoxicity screening and genotoxic impurities. Jacques is member of the Janssen Global Impurity Steering Team and the Johnson&Johnson Genotox Review Committee.

Mark HarrisonPrincipal AnalystAstraZeneca, UK

I have worked for AstraZeneca for 18 years within Operations, Global Medicines Development. In my role as a Mass Spectrometry specialist leading pmi analysis and with a focus on extractable and leachable analysis. My first degree is in Chemistry from Queen Mary University of London, and my I achieved my PhD in Pharmaceutical Chemistry from the The School of Pharmacy and Medicine, University of Bradford. I have a wide range of international publications covering the areas of trace analysis, separation science, extractables and leachables, genotoxins analysis and mass spectrometry.

Carla Landolfi, ERTEuropean RegisteredToxicologist (ERT) R&D,Head of WEP Toxicology -Preclinical DevelopmentAngelini, IT

About 20 years of experience in toxicology field in the pharmaceutical industry. Currently Head of Well Established Products Toxicology at Angelini, an Italian mid-size Pharmaceutical Company. Experience in safety programs for pharmaceuticals, cosmetics, medical devices, biocides and other consumer products. Experience in REACH, Toxicological Risk Assessment, Environmental Risk Assessment; occupational toxicology. Main or co-author of several papers and posters, published in peer-reviewed journals or presented at International Congresses.


SUMMIT2020


BIOGRAPHIES


Mike UrquhartScientific DirectorGlaxoSmithKline, UK

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to Chemistry Manufacturing and Control (CMC) project manager. During his GSK career, Mike has led the primary development / delivery of 10 products, spanning early through to late phase development. Mike’s current roles are GSK CMC Due Diligence lead for small molecules and co-chair of the Genotoxic Risk Assessment (GRA) review team, where he is GSK subject matter expert. Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium.

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Genotoxic Impurities in Pharmaceuticals Summit 2020

PACKAGE NAME Register by 05.06.2020 Register by 19.08.2020 Register by 02.10.2020 Standard price

Individual ticket (2 Days) €1295 (save €500) €1495 (save €300) €1595 (save €200) €1795

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◀ WAYS TO REGISTER

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PACKAGES

EVENTS CALENDAR2019 - 2021

PHARMACEUTICAL LYOPHILIZATION SUMMIT.......................................................................................................................................February 13-14, 2019Prague, Czech RepublicDiscuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.http://qepler.com/pdf/lyo.pdf

HIGHLY POTENT APIs SUMMIT...................................................................................................................................................................February 20-21, 2019Berlin, GermanyAssess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.https://qepler.com/pdf/hpapi.pdf

GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT..........................................................................................................................April 11-12, 2019Berlin, GermanyGTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.https://qepler.com/pdf/genetoxic.pdf

INHALED DRUG DELIVERY SUMMIT...................................................................................................................................................................May 23-24, 2019Berlin, GermanyAssess and harness novel approaches to the development of inhaled drug products for enhanced patient care.https://qepler.com/pdf/inhalation.pdf

2ND ANNUAL PRE-FILLED SYRINGES SUMMIT....................................................................................................................................................June 4-5, 2019Barcelona, SpainEnhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.https://qepler.com/pdf/pfs.pdf

EXTRACTABLES & LEACHABLES SUMMIT..................................................................................................................................................October 15-16, 2019Berlin, GermanyGet the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.https://qepler.com/pdf/enl.pdfREGISTRATION IS OPEN NOW!

2ND ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 4-5, 2019Prague, Czech RepublicGet up to date with the regulatory and quality compliance strategies for combination product development.https://qepler.com/pdf/2ddc.pdfREGISTRATION IS OPEN NOW!

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EVENTS CALENDAR2020

2ND ANNUAL PHARMACEUTICAL LYOPHILIZATION SUMMIT.............................................................................................................February 12-13, 2020Berlin, GermanyOverviewing regulatory updates and advanced technologies, developing lyophilization process that ensure quality at all stages.http://qepler.com/pdf/2lyo.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL HIGHLY POTENT APIs SUMMIT.........................................................................................................................................February 19-21, 2020Prague, Czech RepublicEnhancing HPAPIs manufacturing and handling via new technologies, engineering improvement and successful contamination control strategies.https://qepler.com/pdf/2hpapi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT......................................................................................................................................May 19-20, 2020Prague, Czech RepublicEnsuring safe highly potent aseptic production based on new regulations and technologies implementation.https://qepler.com/pdf/ap.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL PRE-FILLED SYRINGES SUMMIT.................................................................................................................................................May 28-29, 2020Prague, Czech RepublicImproving process development at all stages and enhancing patient safety through new drug delivery systems.https://qepler.com/pdf/3pfs.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL INHALED DRUG DELIVERY SUMMIT............................................................................................................................September 17-18, 2020Prague, Czech RepublicEnhancing respiratory drug delivery and improving patient care through new approaches of product development and advanced technologies.https://qepler.com/pdf/2idd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

MEDICAL DEVICE REGULATIONS SUMMIT...........................................................................................................................................September 22-23, 2020Prague, Czech RepublicExploring EU MDR and IVDR updates and preparing company for new requirements implementation.https://qepler.com/pdf/mdr.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL EXTRACTABLES & LEACHABLES SUMMIT........................................................................................................................October 22-23, 2020Prague, Czech RepublicThe latest developments that accelerate E&L: regulatory requirements, new methodologies, study design, safety assessment.https://qepler.com/pdf/2enl.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CLEANROOM TECHNOLOGY SUMMIT....................................................................................................................................................November 12-13, 2020Prague, Czech RepublicGet the latest updates in cleanroom technologies, new regulations, compliance strategies, engineering and design, EM and contamination control.https://qepler.com/pdf/ct.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT......................................................................................November 19-20, 2020Prague, Czech RepublicGTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.https://qepler.com/pdf/2gti.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 3-4, 2020Vienna, AustriaCombination products development based on regulatory requirements, safety assurance, quality compliance and risk management excellence.https://qepler.com/pdf/3ddc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!








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Whatsapp, Viber: +420 608 030 490


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EVENTS CALENDAR2021

3RD ANNUAL PHARMACEUTICAL LYOPHILIZATION SUMMIT..............................................................................................................February 10-11, 2021Vienna, Austria

http://qepler.com/pdf/3lyo.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL HIGHLY POTENT APIs SUMMIT..........................................................................................................................................February 17-19, 2021Vienna, Austria

https://qepler.com/pdf/3hpapi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

ENVIRONMENTAL MONITORING SUMMIT....................................................................................................................................................March 11-12, 2021Berlin, Germany

http://qepler.com/pdf/em.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

WEARABLE INJECTORS SUMMIT.....................................................................................................................................................................March 25-26, 2021Berlin, Germany

https://qepler.com/pdf/wi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT.............................................................................................................May 20-21, 2021Berlin, Germany

https://qepler.com/pdf/2ap.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

4TH ANNUAL PRE-FILLED SYRINGES SUMMIT.................................................................................................................................................May 27-28, 2021Vienna, Austria

https://qepler.com/pdf/4pfs.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3ND ANNUAL INHALED DRUG DELIVERY SUMMIT............................................................................................................................September 16-17, 2021Vienna, Austria

https://qepler.com/pdf/3idd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL MEDICAL DEVICE REGULATIONS SUMMIT.................................................................................................................September 22-23, 2021Berlin, Germany

https://qepler.com/pdf/2mdr.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CONTAMINATION CONTROL SUMMIT...................................................................................................................................................September 29-30, 2021Prague, Czech Republic

https://qepler.com/pdf/cc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CMC EXCELLENCE SUMMIT..........................................................................................................................................................................October 14-15, 2021Berlin, Germany

https://qepler.com/pdf/2cmc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL EXTRACTABLES & LEACHABLES SUMMIT.........................................................................................................................October 21-22, 2021Vienna, Austria

https://qepler.com/pdf/3enl.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

PHARMACEUTICAL QUALITY RISK MANAGEMENT SUMMIT................................................................................................................ October 28-29, 2021Berlin, Germany

https://qepler.com/pdf/2qrm.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT.........................................................................................November 9-10, 2021Vienna, Austria

https://qepler.com/pdf/3gti.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

INTRADERMAL & TRANSDERMAL DRUG DELIVERY SUMMIT...................................................................................November 16-17, 2021Berlin, Germany

https://qepler.com/pdf/2tdd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL CLEANROOM TECHNOLOGY SUMMIT..........................................................................................................................November 18-19, 2021Berlin, Germany

https://qepler.com/pdf/2ct.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

4TH ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 2-3, 2021Barcelona, Spain

https://qepler.com/pdf/4ddc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!








Whatsapp, Viber: +420 608 030 490




Whatsapp, Viber: +420 608 030 490


summit name to:

DRU

G D

ELIV

ERY

- FO

RMU

LATI

ON

- R&

D -

DEV

ICES

- CO

MBI

NAT

ION

PRO

DU

CTS

- PFS

- LY

OPH

ILIZ

ATIO

N -

E &

L -

IMPU

RITI

ES -

HPA

PI -

INH

ALA

TIO

N -

ASE

PTIC

PRO

CESS

ING

- M

DR

- CM

C - Q

RM -

PFS

- DD

C - E

M



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GENOTOXIC IMPURITIES - Qepler › agendas › 2nd-annual-genotoxic... · 2019-10-07 · Big Data...

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