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PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT 2020 May 19-20, 2020 | Prague, Czech Republic Venue: Novotel Praha Wenceslas Square Hotel Katerinska 38, 120 00 Prague 10+ Program Hours | 8+ Networking Hours Refreshments & Coffee Breaks Business Lunches & Dinner Case Studies & Workshops Roundtable Discussions | Q & A

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Page 1: PHARMACEUTICAL ASEPTIC PROCESSING 2020Aseptic processing simulation: concept creation based on current regulations, process simulation, media fills. ... A3P, SFSTP, SMI, ASPEC, ECA,

PHARMACEUTICALASEPTIC PROCESSINGSUMMIT2020May 19-20, 2020 | Prague, Czech RepublicVenue:Novotel Praha Wenceslas Square HotelKaterinska 38, 120 00 Prague

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

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Klaus UllherrSenior Product Manager Robert Bosch Packaging Technology, DE

Mostafa NakachHead of Formulation & Process Development / Biologics Drug Product DevelopmentSanofi, FR

Dr. Thomas SchwarzHead Strategic Plannning & PMONovartis, CH

Dr. Benedikt ReichartGlobal Business Development Manager,Contract ManufacturingFresenius Kabi, AT

Dr. Olivier ChancelSterility & Aseptic Practices ExpertBoehringer Ingelheim, FR

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WHO YOU WILL MEET

INDUSTRIES◆ Pharmaceutical◆ Biotechnology◆ Chemical◆ Medical Devices◆ CDMOs◆ CMOs◆ CROs

INDUSTRIES◆ NOPs◆ Regulatory Agencies◆ Bioprocessing services and equipment◆ Equipment suppliers◆ Training providers◆ Other

POSITIONS◆ C-Level, Presidents, Chairs, Members of the Board & VPs◆ Vice presidents, Directors, & Heads◆ Leaders & Managers◆ Principals, Engineers, Analysts & Scientists◆ Instructors & Trainers & Teachers◆ Advisors, Coordinators, Auditors & Consultants◆ Other Professionals, Experts & Specialists

DIVISIONS◆ Process Simulation ◆ Process Validation ◆ QA ◆ QbD ◆ QC ◆ Quality management ◆ Regulatory Affairs ◆ Restricted Access Barrier Systems (RABS) ◆ Risk Management ◆ Sanitization ◆ Sterile Products ◆ Sterilization ◆ Validation ◆ Velocity Testing ◆ Visual Inspection ◆ Other

◆ Formulation ◆ GMP ◆ HSE ◆ Industrial Hygiene ◆ Infrastructure management ◆ Isolators ◆ Lyophilization ◆ Maintenance ◆ Manufacturing ◆ Media Fills ◆ Medical Devices ◆ Microbiology ◆ Occupational Safety ◆ Packaging and Labeling ◆ PFS ◆ Plant ◆ Process Engineering

◆ ADC ◆ API/HPAPI ◆ Aseptic processing ◆ Cell and Gene Therapy ◆ CMC ◆ Combination Products ◆ Compliance ◆ Container/Closure Testing ◆ Containment ◆ Contamination Control ◆ Design Control ◆ Environmental Monitoring and Control ◆ Equipment Qualification ◆ Facility ◆ Fill Finish ◆ Filter integrity testing

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

SNAPSHOT OF ATTENDEES - Pharmaceutical Lyophilization Summit 2019:- Bachem AG - Bayer - Bayer Pharmaceuticals - BIOCAD - BioTestLab, Ltd - Boehringer Ingelheim - Boehringer Ingelheim Animal Health - CONTIPRO a.s. - CSL Behring AG - CSLBehring GmbH - Datwyler Pharma Packaging International NV - De Montfort University - Ghent University - GOETHE Biotechnology GmbH - iQ-mobil solutions GmbH/Tempris - Janssen Pharmaceutica NV - Kingston University London - Laboratoire Aguettant - Lonza AG - Lyofal - Martin Christ Gefriertrocknungsanlagen GmbH - MediWound - MSD International - Novartis - oncomed manufacturing a.s. - Patheon - PIGO srl - Sanofi Pasteur - sfm medical devices GmbH - Shire - Skan AG - SP Scientific - Takeda - Takeda GmbH - Takeda Vaccines - UCL School of Pharmacy - Vaxxinova Int. - Weibo Hi-tech Group - Others

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 - Others

SNAPSHOT OF ATTENDEES - Pre-Filled Syringes Summit 2018:- AbbVie - Accord Healthcare - Aptar Pharma - Aristo Pharma - Bayer - Becton Dickinson - Bespak Europe - Bioton - Bristol-Myers Squibb - Cambridge Consultants - Celanese - Corvus Device Datwyler - F. Hoffmann-La Roche - Flex - GlaxoSmithKline - Hekuma - HTL-STREFA - Intertek - Janssen - Laboratoire Aguettant - Medac - Merck Group - Novartis - Novo Nordisk - Pall Life Sciences - RAUMEDIC - Sanofi - SCHOTT Pharmaceutical Packaging - SHL Group - Solvias - Sonceboz - STADA Arzneimittel - Stevanato Group - Terumo Europe - TOPAS Advanced Polymers - West Pharmaceutical Services - Worrell - Others

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

May 19-20 | Prague, Czech Republic

Annex 1 and aseptic processing - compliance with the guide. Considerations for implementation. Regulatory framework. Aseptic Processing principles. Preparing for regulatory inspections.

Antibody Drug Conjugates / HPAPIs production: aseptic processing of ADCs / HPAPIs - complying with regulatory requirements, ensuring aseptic fill-finish, empowering cleaning, preventing cross contamination, providing occupational safety.

Lyophilization of highly potent products and aseptic processing.

Aseptic process development, validation and evaluation. QRM for aseptic processing. Reviewing main results, challenges and considerations achieved in aseptic manufacturing.

Aseptic processing simulation: concept creation based on current regulations, process simulation, media fills.

Pharma 4.0: Innovations and advanced aseptic manufacturing technologies. New ways for manufacturing excellence. Automated Solutions.

Highly potent facility design and engineering considerations: building safe aseptic production at each stage. Conceptual design, basic engineering, detail engineering, implementation, installation. Equipment and utilities overview, room installation, cleaning and waste management. Creating a new aseptic filling

line.

Isolator Technology use in aseptic processing for loss minimization/elimination. Cycle time reduction.

Ensuring safe production for both sides (manufacturer and patient) through innovations and data sciences.

Eliminating operator impact on production via barrier systems. Restricted Access Barrier Systems.

Robotics use in aseptic processing. Modernisation of the traditional lines. New facility installation. Future, advantages and disadvantages.

Overcoming technical challenges in decontamination processes and material transfers. H2O2 decontamination – ensuring production robustness.

Ageing facilities: choosing between upgrade and renovation. Overviewing 2 cases and ways to ensure required aseptic manufacturing.

Contamination control program- cleaning and disinfection programs for aseptic facilities. Current regulations and guidance. Contamination control principles. Sterility and cleanliness of product/non-product contact surfaces. Ensuring controlled environments though disinfection and cleaning procedures. Validation

protocols creation for cleaning systems implementation. Antimicrobial testing.

Airflow visualization for contamination risks assessment.

Implementing containment technologies in aseptic processing – step by step strategy.

Cross contamination prevention and control for highly potent products. VR use for cross contamination prevention.

Boosting sterilization: successful strategies, advanced technologies implementation. Sterility testing.

Sterility assurance in aseptic processing using microbial monitoring and advanced techs implementation. Regulations. Environmental monitoring design based on process analysis, risk assessment, new technologies and instruments. Components determination.

Applying QbD, ICH Q9, risk management to improve aseptic processing and sterility assurance. Aseptic process analysis and QbD based design.

Cleanroom examination, cleaning and disinfection procedures, mistakes identification. Cleaning automation and technologies.

Gowning: procedures, training, personnel qualification.

Microbiology techniques use in aseptic processing

Integrating sanitization techniques to empower contamination control.

Filtration: filter integrity testing in aseptic processing.

Single-use systems implementation.

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

PROPOSED TOPICS

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

May 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

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

12:50 - 13:50 🍽 Business lunch

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

13:50 - 14:20

Case Study 2

Workshop 1

Case Study 3

Slot Reserved for a Gold or Silver Sponsor

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

May 19 | Prague, Czech Republic

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

18:00 - 18:10 🎤 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 -17:00

17:00 -18:00 💡 Roundtable Discussion

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

Case Study 4 - Reserved

Mostafa Nakach | Head of Formulation & Process Development / Biologics Drug Product Development | Sanofi, FR

Slot Reserved for a Booth or Bronze Sponsor

Site Transformation Stein Steriles: From Small Molecule to Combination Product Processing◆ 20 years of sterile manufacturing◆ Evolution of filling technologies (ampoules, vials, prefilled syringes)◆ Launch Excellence◆ Development of technologies ◆ Change of portfolio and ◆ Combination products

Dr. Thomas Schwarz | Head Strategic Plannning & PMO | Novartis, CH

Case Study 6 - Reserved

Dr. Benedikt Reichart | Global Business Development Manager,Contract Manufacturing | Fresenius Kabi, AT

Topics

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

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

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

08:40 - 09:20

10:50 - 11:10

09:20 - 10:20

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

10:20 - 10:50 🍵 Morning coffee and networking break

11:10 - 12:10

Workshop 1

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 - Reserved

Klaus Ullherr | Senior Product Manager | Robert Bosch Packaging Technology, DE

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

May 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 - Reserved

Dr. Olivier Chancel | Sterility & Aseptic Practices Expert | Boehringer Ingelheim, FR

Case Study 3

Case Study 4

16:00 - 16:20 💡 Q & A

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

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PHARMACEUTICAL ASEPTIC PROCESSING

SUMMIT2020

May 19-20 | Prague, Czech Republic

BIOGRAPHIES

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

Dr. Thomas SchwarzHead Strategic Plannning & PMONovartis, CH

Thomas Schwarz started his career in the pharmaceutical industry 20 years ago as a production manager at Sanofi in biotech production.He joined Novartis in 2006 and has held several positions with increasing responsibility (e.g. Process Manager, QC Team Head, Project Manager) in different technology areas like sterile manufacturing, QC operations and clinical supply management.In his current role, Thomas oversees the long-term planning and strategic projects of the Aseptics platform (6 sites worldwide).Thomas holds a PhD in Chemistry and has completed an executive MBA program.

Klaus UllherrSenior Product Manager Robert Bosch Packaging Technology, DE

Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid. During the first two years he was project manager responsible for handling complex customer orders. Since 2002 he is product manager for the business fields syringes and filling systems with global product responsibility. His main functions are * Market analysis * Business development * Initiating new product developments * Expert for syringe processing He is member of the «PDA Interest Group pre-filled syringes» and works as an expert in the DIN/ISO group for primary packaging. Klaus is also member of ISPE and co-track-leader of the yearly ISPE Aseptic Conference. He is a well-known speaker on conferences covering trends and solutions for fill/finish equipment especially for pre-filled syringes, other pre-sterilized containers and single-use-filling-systems.

Dr. Benedikt ReichartGlobal Business Development Manager,Contract ManufacturingFresenius Kabi, AT

Benedikt acts as the first point of contact for pharmaceutical companies planning the outsourcing of manufacturing of sterile pharmaceuticals at Fresenius Kabi’s manufacturing sites in Europe and Asia. Benedikt joined Fresenius Kabi as a Management Trainee after completing his PhD in Organic Chemistry from the Karl-Franzens University of Graz, Austria in 2014. He afterwards covered the role of executive assistant at Fresenius Kabi focusing on pharmaceutical manufacturing, global investments, strategy roll-out, capacity and supply chain management.

Dr. Olivier ChancelSterility & Aseptic Practices ExpertBoehringer Ingelheim, FR

Dr. Olivier Chancel is a doctor pharmacist, graduating in technological pharmacy, quality control and management. Currently, he is the sterility and aseptic practice assurance expert and formerly head of performance and pharmaceuticals in Merial, Toulouse, France. He provides corporate support for sterility and aseptic processes to Merial sites. He used to work in the pharmaceutical industry for 15 years in various positions including pharmaceutical research and development, quality assurance, quality control, project management and production for both solid and injectable dosage forms. He has published a number of papers in peerreviewed journals relating to cleanroom activities or aseptic practices and also presented/moderated at various industry forums in Europe and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG...)

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PACKAGE NAME Register by 08.11..2019 Register by 10.01.2020 Register by 03.04.2020 Standard price

Individual ticket (2 Days) €1395 (save €500) €1595 (save €300) €1695 (save €200) €1895

Individual ticket (1 Day) €795 (save €200) €845 (save €150) €895 (save €100) €995

Group ticket ( 2-3 delegates) €1195 (save €600) €1395 (save €400) €1495 (save €300) €1795

Group ticket ( 4+ delegates ) €995 (save €700) €1095 (save €600) €1195 (save €500) €1695

Non-profit organizations €695 (save €300) €795 (save €200) €895 (save €100) €995

REGISTRATION FORM This registration form is editable. When you have completed the form - please save and email it to [email protected]

SUMMIT NAME:

REGISTRATION DATE:

TOTAL PRICE:

PROMOCODE:

PACKAGE NAME:

PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT 2020

© All rights reserved Qepler s.r.o. 2019

REGISTRATION & PAYMENTUpon receiving the signed registration form, we will process your application. The registration confirmation and the invoice will be sent to you within one (1) working day with the relevant payment instructions and terms. The registration fee includes access to all sessions, coffee breaks, lunches, dinner and conference materials. Payment is due 10 working days from the invoice date. Payment should be made by Credit Card, Pay Pall or by Bank Transfer. The delegate is responsible for any bank charges/fees associated with the payment.

CANCELLATION & SUBSTITUTION POLICYYou may substitute a delegate at any time and at no extra cost. Cancellations must be in a written notice. Cancellations made 30 days or more before the event start date will be refunded less than 50% of the registration fee. Cancellations made less than 30 days before the event start date will receive no refund. If you cannot attend an event due to illness or other unforeseen circumstances, you may transfer your delegate pass to another upcoming event within one year from original event start date.

EVENT CHANGES & CANCELLATIONSWhile all effort will be made to adhere to the advertised package, Qepler s.r.o. reserves the right to change event dates, sites or location, omit event features, or merge the event with another event as it deems necessary without penalty. In such situations no refunds, part refunds or alternative offers will be made. In the event that Qepler s.r.o. permanently cancels the event for any reason, and provided that the event is not postponed to a later date nor is merged with another event, you will receive a credit note or refund for 100% of the conference fee paid. Please note, Qepler s.r.o. will not be held liable for any accommodation or associated travel costs should the event be canceled or rescheduled.

DATA PROTECTIONThe personal information provided by you will be held in the Qepler database. For data update please write to [email protected].

TERMS & CONDITIONS

Business Dinner (Feb 20) €45

Documentation €499 Promotional materials distribution €699 Speaker €2495 Pop up stand €3495 Bronze €4095

Booth €5495 Silver €6995 Gold €7995

SPONSORSHIP PACKAGES

DELEGATEPACKAGES

PLEASE MARK if you will join the Business Dinner on February 20th

ATTENDEE DETAILS

1ST ATTENDEE 2ND ATTENDEE 3RD ATTENDEE 4TH ATTENDEE 5TH ATTENDEE 6TH ATTENDEE

Title:

Name:

Surname:

Company:

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Direct phone:

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Special Requirenments:(If you have any special dietary requirements or other needs that would enhance your enjoyment of this summit, please specify)

Title: Name: Surname:

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Signature: ✍«I agree to be bound by Terms and Conditions of registration»

INVOICE DETAILS:

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MARKETING CAMPAIGN✓Website ✓Email Marketing ✓Digital Advertising ✓Social Marketing ✓Press ✓Direct SalesPARTICIPATION FEEFees are inclusive of the 2-day summit, materials, online post-event documentation/presentation package, lunches, snacks, refreshments and business dinner. TRAVEL AND ACCOMMODATIONHotel accommodation and travel expenses are not included in the fee. Special rates for the event venue will be sent upon availability. VENUEEvent venue will be announced online and sent to the delegates within a reasonable period before the summit start date.POST-EVENT DOCUMENTATIONPresentations and other materials will be sent to the attendees within 72 hours after the event. Presentation content is subject to speaker's approval for distribution.DISCOUNTSEarly booking discounts are not valid in conjunction with any other offer.

SPONSORSHIP PACKAGES

BENEFITSSPEAKER

€2495POP UP STAND€3495

BRONZE€4095

BOOTH€5495

SILVER€6995

GOLD€7995

Number of passes included 1 1 2 2 3 4

Registration fee for additional company representatives €1295 €1295 €1195 €1195 €1095 €1095

Coupon (1 free pass for the other Qepler events) ● ●Pop up stand in the break area (3m wide x 3m height; includes 1 table, chairs, 1 electrical socket) ● ●Exhibition booth with LCD monitor for video presentations in the break area (3m wide x 3m deep; includes 1 table, chairs, 1 electrical socket)

● ● ●

Pull-up banner at the entrance to the auditorium (to be provided by sponsor) ● ●Speaking slot 20 min 20 min 20 min 30 min 30 min

Opening keynote presentation 15 min

Recognition in chairman’s opening address ● ● ● ● ● ●Seat on a panel discussion ● ● ● ●Opening & closing speech ●Chairman of Day 1 ●Chairman of Day 2 ●Logo and URL on summit website, agenda and pre/post-summit communication activities ● ● ● ● ● ●Recognition on Qepler social media channels (LinkedIn/Facebook/Twitter/Instagram) ● ● ● ● ● ●Colour advert in placed in agenda 1/4 Page 1/4 Page 1/2 Page 1 Page

Company flyer/brochure included in conference folder (to be provided by sponsor) ● ● ● ●Online distribution of your company’s promotional materials to all attendees ● ● ● ●Lanyards for summit badges, notepads, pens and other promotional materials (max. 5) given to all participants and speakers (to be provided by sponsor)

ONLINE PACKAGES

If you are unable to attend, you may purchase these packages:

PACKAGE NAME PRICE

DOCUMENTATIONPost-event presentations and other materials. Presentation content is subject to speaker's approval for distribution.

€499

PROMOTIONAL MATERIALS DISTRIBUTION(Distribution of your company’s promotional materials to all attendees)

€699

◀ WAYS TO REGISTER

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

PACKAGES

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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!

PHARMA - MEDICAL DEVICES - CHEMISTRY

CLICK HERE TO REQUEST INFORMATION:

Please choose the Summit / Summits and send us suggested Session Title via email or webpage.

We will appreciate if you share our calendar with your colleagues!

Denis PolikarpovExecutive Director

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/denis-polikarpov-conferences/

Whatsapp, Viber: +420 608 030 490

Evgenia MakarCo-founder & Chief Executive Officer

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/evgenia-makar/

Whatsapp, Viber: +420 608 030 490

CONTACTSPlease send your session title and

summit name to:

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🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected] © All rights reserved Qepler s.r.o. 2018

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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!

PHARMA - MEDICAL DEVICES - CHEMISTRY

CLICK HERE TO REQUEST INFORMATION:

Please choose the Summit / Summits and send us suggested Session Title via email or webpage.

We will appreciate if you share our calendar with your colleagues!

Denis PolikarpovExecutive Director

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/denis-polikarpov-conferences/

Whatsapp, Viber: +420 608 030 490

Evgenia MakarCo-founder & Chief Executive Officer

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/evgenia-makar/

Whatsapp, Viber: +420 608 030 490

CONTACTSPlease send your session title and

summit name to:

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🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected] © All rights reserved Qepler s.r.o. 2018

Page 14: PHARMACEUTICAL ASEPTIC PROCESSING 2020Aseptic processing simulation: concept creation based on current regulations, process simulation, media fills. ... A3P, SFSTP, SMI, ASPEC, ECA,

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!

PHARMA - MEDICAL DEVICES - CHEMISTRY

CLICK HERE TO REQUEST INFORMATION:

Please choose the Summit / Summits and send us suggested Session Title via email or webpage.

We will appreciate if you share our calendar with your colleagues!

Denis PolikarpovExecutive Director

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/denis-polikarpov-conferences/

Whatsapp, Viber: +420 608 030 490

Evgenia MakarCo-founder & Chief Executive Officer

Tel: +420 608 030 490Email: [email protected]

LinkedIn: https://www.linkedin.com/in/evgenia-makar/

Whatsapp, Viber: +420 608 030 490

CONTACTSPlease send your session title and

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

🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected] © All rights reserved Qepler s.r.o. 2018