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1st EditionConference

Extractables & Leachables Summit

15 - 16 Oct 2019 New Date Reminder
Hotel NH Collection Berlin Friedrichstrasse, Berlin, Germany
AboutFollowers 1ExhibitorsSpeakers 13ReviewsPhotos 51Travel Deals
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"Latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility."
Extractables & Leachables Summit will focus on patient needs in terms of ease of use and safety, becomes a strategic imperative. It is a platform for attendees to explore the emerging role of smart devices, map the importance of drug/packaging/device interactions, optimize the selection of delivery systems for a drug product, showcase applications for complex formulations, highlight the right parameters for a primary packaging container, and much more.

Highlights

  • USP 665 draft standard
  • Strategies for assessment of impurities and E&Ls
  • Leachables strategies for finished biopharmaceuticals
  • Extractables and Leachables challenges of for prefilled syringes
  • Toxicological assessment of non-genotoxic E&L

Timings

7:30 AM - 5:00 PM (General)

Entry Fees

Paid Ticket Starts from 795 EUR
Exhibit Booth Cost Starts from 5495.01 EURView Details

Estimated Turnout

60
Delegates

2 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma

Editions

Oct 2019 1st Edition


Frequency Annual

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Prague, Czech Republic22 - 23 Oct 2020
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QeplerTop Rated

Czech Republic26 Total Events / 1 Upcoming Event

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Speakers

Schedule & Agenda

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Tue, 15 Oct 07:50 AM - 08:30 AM Registration
Registration and Welcome Coffee
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Tue, 15 Oct 08:30 AM - 08:40 AM Opening Ceremony
Opening Address from the Chairman
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Tue, 15 Oct 08:40 AM - 09:20 AM Session
USP <665> draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems
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Dr. Simone Biel | Field Marketing Single Use Technology | Merck Millipore, DE
Dr. Simone Biel
Dr. Simone Biel Field Marketing Single Use Technology at Merc..
Tue, 15 Oct 09:20 AM - 10:00 AM Networking
Speed Networking
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Tue, 15 Oct 10:00 AM - 10:40 AM Session
Strategies for assessment of impurities and E&Ls
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Prof. Dr. Johannes Harleman | Independent Consultant
Prof. Dr. Johannes Harleman
Prof. Dr. Johannes Harleman Independent Consultant
Tue, 15 Oct 10:40 AM - 11:10 PM Break
Morning coffee and networking break
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Tue, 15 Oct 11:10 AM - 11:40 AM Session
Safety assessment of extractables/leachables: Challenges with different administration routes
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Dr. Christian Trendelenburg | Senior Toxicologist & Project Leader (PTM) |Novartis, CH
Dr. Christian Trendelenburg
Dr. Christian Trendelenburg Senior Toxicologist & Project Leader (PTM) at..
Tue, 15 Oct 11:40 AM - 12:20 PM Session
Toxicological assessment of non-genotoxic E&L
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Dr. Clemens Günther | Director Nonclinical Safety Consumer Care | Bayer AG, DE
Dr. Clemens Günther
Dr. Clemens Günther Director Nonclinical Safety Consumer Care at ..
Tue, 15 Oct 12:20 PM - 12:45 PM Session
Challenges and pitfalls during E&L studies and how to handle them
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Dr. Tino Otte | Senior Scientific Consultant | Intertek (Schweiz) AG, CH
Dr. Tino Otte
Dr. Tino Otte Senior Scientific Consultant at Intertek (Sch..
Tue, 15 Oct 12:45 PM - 01:45 PM Lunch
Business lunch
Tue, 15 Oct 01:45 PM - 02:10 PM Session
Session
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RESERVED FOR GOLD, SILVER OR BOOTH SPONSOR
Tue, 15 Oct 02:10 PM - 02:50 PM Session
Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design
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Andrew Feilden | Technical director | Smithers Rapra Ltd., UK
Andrew Feilden
Andrew Feilden Technical director at Smithers Rapra Ltd.
Tue, 15 Oct 02:50 PM - 03:30 PM Session
Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration
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Dr. Roberto Menzel | Laboratory Supervisor and Manager Extractables |Sartorius Stedim Biotech, DE
Dr. Roberto Menzel
Dr. Roberto Menzel Laboratory Supervisor and Manager Extractable..
Tue, 15 Oct 03:30 PM - 04:00 PM Break
Afternoon coffee and networking break
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Tue, 15 Oct 04:00 PM - 04:40 PM Session
Data Integrity
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Rick Reiley | Principal Scientist | GlaxoSmithKline, UK
Rick Reiley
Rick Reiley Principal Scientist at GlaxoSmithKline
Tue, 15 Oct 04:40 PM - 05:20 PM Session
Session
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To Be Announced
Tue, 15 Oct 05:20 PM - 05:50 PM Roundtable
Panel Discussion
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Tue, 15 Oct 05:50 PM - 06:00 PM
Chairman’s closing remarks and end of day one
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Tue, 15 Oct 07:00 PM - 09:00 PM Dinner + Cocktail
Business dinner
Wed, 16 Oct 08:00 AM - 08:30 AM Registration
Registration and Welcome Coffee
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Wed, 16 Oct 08:30 AM - 08:40 AM
Opening Address from the Chairman
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Wed, 16 Oct 08:40 AM - 09:20 AM Session
Extractables and Leachables challenges of for prefilled syringes
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Carsten Worsøe | Principal Scientist | Novo Nordisk A/S, DK
Carsten Worsøe
Carsten Worsøe Principal Scientist at Novo Nordisk A/S
Wed, 16 Oct 09:20 AM - 10:00 AM Session
Leachables strategies for finished biopharmaceuticals
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Dr. Andreas Nixdorf | Life Sciences - Business Development ManagerExtractables & Leachables Testing | SGS Institut Fresenius GmbH, DE
Dr. Andreas Nixdorf
Dr. Andreas Nixdorf Life Sciences - Business Development Manager ..
Wed, 16 Oct 10:00 AM - 10:30 AM Break
Morning coffee and networking break
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Wed, 16 Oct 10:30 AM - 11:10 AM Session
The rubber formulation composition and its impact on extractables and leachables
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Bram Jongen | Head of R&D, PPS | Datwyler Pharma Packaging International NV, BE
Bram Jongen
Bram Jongen Head of R&D, PPS at Datwyler Pharma Packaging..
Wed, 16 Oct 11:10 AM - 12:00 PM Session
Extractables from Rubber Closures – Assessment and Control
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Dr. Bettine Boltres | Principal Scientific Affairs, Packaging & Delivery Systems |West Pharmaceutical Services Deutschland GmbH & Co KG, DE
Dr. Bettine Boltres
Dr. Bettine Boltres Principal Scientific Affairs, Packaging & Del..
Wed, 16 Oct 12:00 PM - 01:00 PM Lunch
Business lunch
Wed, 16 Oct 01:00 PM - 01:40 PM Session
Session
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To Be Announced
Wed, 16 Oct 01:40 PM - 02:20 PM Session
Adoption of standardized extractables datasets for single-use system qualification and risk assessment
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Dr. Gilbert Tumambac | Sr. Principal Scientist | Pall Biotech, USA
Dr. Gilbert Tumambac
Dr. Gilbert Tumambac Sr. Principal Scientist at Pall Biotech
Wed, 16 Oct 02:20 PM - 02:50 PM Break
Afternoon coffee and networking break
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Wed, 16 Oct 02:50 PM - 03:30 PM Session
Session
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To Be Announced
Wed, 16 Oct 03:30 PM - 04:10 PM Session
Session
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To Be Announced
Wed, 16 Oct 04:10 PM - 04:20 PM Closing Ceremony
Chairman’s closing remarks and end of day two
#Rome

Visitor Ticket Price

795 EURIndividual ticket (1 Day)Register by 16.08.2019
895 EURGroup ticket ( 4+ delegates )Register by 16.08.2019
1195 EURGroup ticket ( 2-3 delegates)Register by 16.08.2019
1395 EURIndividual ticket (2 Days)Register by 16.08.2019

Exhibit Space Cost

Exhibition booth with LCD monitor for video presentations in the break area (3m wide x 3m deep; includes 1 table, chairs, 1 electrical socket) (32 sq.mt.)

EUR 5495.01

52.51961613.388773

Venue Map & Directions

map of Hotel NH Collection Berlin Friedrichstrasse
Rome

Friedrichstrasse 96, 10117 Berlin
Germany

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