Tentamus Pharma & Med Webinar Series - Oct - Nov 2020
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
PHARMA & MED WEBINAR SERIES 2020
Tentamus Pharma & Med Webinar Series
26. Oct - 06. Nov 2020
Tentamus Pharma Webinar Topics:
Series 2020
SERIES 1 – Focus on Medical Devices - Biocompatibility Testing
In times of COVID-19 we are offering our
clients an opportunity to stay connected SERIES 2 – Focus on Microbiological Aspects in Drug and Biotherapeutic
and informed from the convenience of your
labs, homes, or offices. SERIES 3 – Biomolecules & Analytics
Attend our webinars from 26th October SERIES 4 – Special Topic in Analytics
until 06th November 2020.
SERIES 5 – The Analytical World of Herbal Medicines
Participate in our webinars, where you’ll
get access to expert know-how. Our SERIES 6 – Medical Cannabis Analytics
experts are specialists in their fields of
scientific research or routine quality SERIES 7 – Pre-Clinical - Clinical & Analytics
control.
You’ll learn about the newest tools and
technologies while gathering valuable
tips and troubleshooting strategies for
the applications most relevant to your
processes or products. Registration and participation in these webinars are FREE for everyone.
Registered participants receive a certificate of participation after the webinar.
During the sessions you have the chance
to ask questions about your toughest
analytical challenges or discuss specific Register via Email at webinar@tentamus.com
topics.
First Week: October 26 - 30, 2020
Time MONDAY, TUESDAY, WEDNESDAY, THURSDAY, FRIDAY,
(CET) OCT 26 OCT 27 OCT 28 OCT 29 OCT 30
10:00 Introduction to the Stability Studies, In- Nitrosamines in API Design of Experiments Monocyte Activation Test –
World of Bioanalytics Use Stability for Herbal & Finished Products for Process Optimization Determination of Material
Speaker: Ayelet Nudelman, PhD Medicines Speaker: Martin Linkogel Speaker: Rainer Fedra Dependent Pyrogenicity
Speaker: Petra Heller Speaker: Larissa Nkenmei-
Pietsch
11:00 Bioanalytical Chromatographic Method Qualification & Trouble- Analytical Method Evaluation of
Considerations in the Development for Herbal Shooting in a Quality Portfolio of Therapeutic Biological Safety:
Design of Pre-Clinical Drugs Control Lab for HPLC, Antibodies – Testing Interaction with Blood
& Clinical Trials Speaker: Steve Ross HPLC-MS and GC Abilities for Fab & Fc “Hemocompatibility:
Speaker: Ayelet Nudelman, PhD Speaker: Lars Henning Part as well as Functional ISO 10993-4
Assays based on their Speaker: Dr. Wolfgang Rudy
Mode of Action
Speaker: Markus Roucka
14:00 Challenges in Cannabinoid OOS of Herbal Medicinal FcG Receptor Testing - Microbiological
Formulation Analysis Products A Short Introduction to Aspects for Non-Sterile
Speaker: Amit Becker Speaker: Katherina Rüger the Why & How of Fc Pharmaceutical Products
Receptor Binding Analysis Speaker: Dr. Bernhard
Speaker: Markus Roucka Fellenberg Biocompatibility Testing
of Medical Devices
according to ISO 10993 –
View from a Testing
Laboratory & a
Pyrrolizidine Alkaloids Understanding SPR Microbial & Bacteriophage Consultancy
15:00 Medical Cannabis:
Contamination Testing
in Herbals (Biacore) Binding Kinetics Speaker: Ralf Sibbing /
Specifications,
Speaker: Arne Dübecke and Affinity - What are in Live Biotherapeutic Dr. Dominik Herzog
Monographs, „Critical“
ka, kd & KD, and How to Products (LBP) and
Parameters for Analytics,
Interpret Them? Microbial Cell Banks
Regulatory Aspects from
Speaker: Simon Gaderer Speaker: Rafal Napierala /
Narcotic Point of View
Linda Schmitt
Speaker: Dr. Johannes
Junemann
Second Week: November 02 - 06, 2020
Time MONDAY, TUESDAY, WEDNESDAY, THURSDAY, FRIDAY,
(CET) NOV 02 NOV 03 NOV 04 NOV 05 NOV 06
10:00 OOS of Herbal Medicinal Challenges in Cannabinoid Microbiological FcG Receptor Testing -
Products Formulation Analysis Aspects for Non-Sterile A Short Introduction to
Speaker: Katherina Rüger Speaker: Amit Becker Pharmaceutical Products the Why & How of Fc
Speaker: Dr. Bernhard Biocompatibility Testing Receptor Binding Analysis
Fellenberg of Medical Devices Speaker: Markus Roucka
according to ISO 10993 –
View from a Testing
Laboratory & a
11:00 Pyrrolizidine Alkaloids Medical Cannabis: Microbial & Bacteriophage Consultancy Understanding SPR
in Herbals Specifications, Contamination Testing Speaker: Ralf Sibbing / (Biacore) Binding Kinetics
Speaker: Arne Dübecke Monographs, „Critical“ in Live Biotherapeutic Dr. Dominik Herzog and Affinity - What are
Parameters for Analytics, Products (LBP) and ka, kd & KD, and How to
Regulatory Aspects from Microbial Cell Banks Interpret Them?
Narcotic Point of View Speaker: Rafal Napierala / Speaker: Simon Gaderer
Speaker: Dr. Johannes Linda Schmitt
Junemann
14:00 Stability Studies, In- Nitrosamines in API Introduction to the Monocyte Activation Test – Design of Experiments
Use Stability for Herbal & Finished Products World of Bioanalytics Determination of Material for Process Optimization
Medicines Speaker: Martin Linkogel Speaker: Ayelet Nudelman, PhD Dependent Pyrogenicity Speaker: Rainer Fedra
Speaker: Petra Heller Speaker: Larissa Nkenmei-
Pietsch
15:00 Chromatographic Method Qualification & Trouble- Bioanalytical Evaluation of Analytical Method
Development for Herbal Shooting in a Quality Considerations in the Biological Safety: Portfolio of Therapeutic
Drugs Control Lab for HPLC, Design of Pre-Clinical Interaction with Blood Antibodies – Testing
Speaker: Steve Ross HPLC-MS and GC & Clinical Trials “Hemocompatibility: Abilities for Fab & Fc
Speaker: Lars Henning Speaker: Ayelet Nudelman, PhD ISO 10993-4 Part as well as Functional
Speaker: Dr. Wolfgang Rudy Assays based on their
Mode of Action
Speaker: Markus Roucka
Our Speakers
Amit Becker Dr. Johannes Junemann
Study Director @ Analyst Research Laboratories (Israel) Head of Quality Control, Responsible Person for Narcotics @ QSI
(Germany)
• About 13 years of experience in analytical chemistry,
including 8 years of experience in pharmaceutical analysis, • PhD in biomedicine with focus on instrumental analysis
in the fields of analytics (R&D & QC) and also bioanalytics • More than 7 years’ experience in instrumental analysis and
over 2 years’ experience in GMP compliant quality control
and narcotics law
Arne Dübecke
Business Unit Manager Food Authenticity & Medical Devices
@ QSI and Head of Tentamus Center for Food Fraud (TCF2) Katherina Rüger
(Germany) Head of Quality Assurance @ DSI-pharm (Germany)
• Active member of the AOAC Food Authenticity & Fraud Panel • Master of Science Chemistry
and the committee on food authenticity of DIN • Previous experience in ISO 17025, in the field of food and
• Expert in the verification of authenticity and detection of feed analysis, Element analysis via ICP-OES and ICP-MS
adulteration of foodstuffs
Ayelet Nudelman, PhD
Study Director @ Analyst Research Laboratories (Israel) Lars Henning
Technical Manager, Assistant Lab Manager @ QSI (Germany)
• PhD in Chemistry from Bar-Ilan University
• Working at Analyst for the last 16 years, more than 12 years • Biochemist, working for QSI since end of 2017
experience in Bioanalytics • Before he was working as product specialist for preparative
• In charge on all GLP and GCLP projects at Analyst HPLC-systems with experience in system engineering and
qualification for almost 10 years
Dr. Bernhard Fellenberg
Business Development & Scientific Manager @ BAV Institut
(Germany) Larissa Nkenmei-Pietsch
Head of Cell-and Immune Analytics @ TentaMedix (Germany)
• Food chemist, PhD in microbiology, more than 10 years
expertise in regulatory affairs for drugs & cosmetics • Biologist with a special focus in Cell- and Immune Analytics
• Head of Working Group Cosmetics at the German Society of • More than 5 years experience in quality control with the main
German Chemists focus on cell culture based bioassays, in-vitro toxicology
testing and immunological based assays
Dr. Dominik Herzog
Managing Director @ TentaMedix (Germany)
• Biochemist by education
• Experienced in the preclinical research area in the field of
neurobiology plus more than 5 years in a FDA inspected
pharmaceutical quality control laboratory
Our Speakers
Martin Linkogel Ralf G. Sibbing
Certified Food Chemist @ QSI (Germany) Managing Partner @ TentaConsult (Germany)
• 20 years experience in analytical chemistry, quality control • Specialised pharmacist by education & Qualified Person
food and pharma • Worked in the consultancy for medicinal products, medical
• Expertise in quality control of honey & bee products, devices and other healthcare products for more than 24
veterinary drugs residue testing by LC-MS/MS, method years covering regulatory affairs, quality management and
development & validation for pharm. product development safety
Markus Roucka Simon Gaderer
Managing Director/ CBDO @ VelaLabs (Austria) Group Leader Ligand Binding Assays @ VelaLabs (Austria)
• Expertise in assay development and assay optimization to • More than 8 years of experience in protein analytics in the
leadership and project management areas of assay development and quality control under GMP
• Lecturer at the IMC Krems & trainer at various organizations and GCLP regulations
(European Compliance Academy ECA, Fleming Group, etc) • His focus includes SPR (Biacore), ELISA and ECL analytics
Petra Heller
Senior Project Manager @ DSI-pharm (Germany) Steve Ross
Manager Laboratory @ DSI-pharm (Germany)
• Graduate chemist
• 7 years experience in environmentals analytics, 13 years • B.Sc. Chemistry, University of Reading (England)
experience in pharmaceutical analytics • Experiences fields - Over 30 years experience in
pharmaceutical analysis, mostly in the field of HPLC-analysis
of herbal drugs
Rafal Napierala
Head of Microbiology & Bacteriophage Analytics @ TentaMedix
(Germany)
Dr. Wolfgang Rudy
• Biotechnologist by education CSO @ TentaMedix (Germany)
• More than 9 years in quality control - main focus on microbial • Biologist with a special focus in Cell- and Immune Analytics
cell banks characterization, live biotherapeutics safety and an excellent track record in academic science
assessment, bacteriophage R&D, biological impurities testing • More than 20 years in the biotech industry & successfully
established in-vitro toxicology testing and Bioanalytics
Rainer Fedra
Head of Research and Development @ VelaLabs (Austria)
• Studied Pharmaceutical Biotechnology
• More than 11 years of experience in the fields of Quality
Control, Assay Development and Clinical Analytics
• Lecturer for Concept Heidelberg, the Fleming Group and the
University of Applied Sciences Krems
Do you have any questions or would you like to register?
Get in touch
webinar@tentamus.com
+49 441 361 326 54 47
DSI-pharm TentaMedi BIOANALYTICS
Consult
Pharma & Med
You can also read
