This document provides the program details for the 4th Jerusalem Conference on Quality and Pharma Sciences taking place on May 20-22, 2014 at the Belgium House on the Edmond J. Safra Campus of the Hebrew University of Jerusalem. The conference will focus on applications of quality by design (QbD) to pharmaceutical sciences through presentations and panel discussions on topics including analytical methods, design of experiments, regulatory updates, QbD in development and quality challenges. It includes the schedule, list of speakers and organizers, sponsors and registration information.
ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicit...NAMSA
ISO 10993-3: Biological Evaluation of Medical Devices discusses how to identify when genotoxicity, carcinogenicity or reproductive toxicity testing is necessary for a medical device.
ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicit...NAMSA
ISO 10993-3: Biological Evaluation of Medical Devices discusses how to identify when genotoxicity, carcinogenicity or reproductive toxicity testing is necessary for a medical device.
ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effec...NAMSA
ISO 10993-6 helps identify appropriate implantation sites, how long implants should remain in place during testing, implantation methods and biological responses at the macro- and microscopic level.
Although other departments of the government shall look after market completion, polices etc. BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
Inhalation & Respiratory Drug Delivery SummitDiogo Ribeiro
The IRDD Summit will focus on the challenges of bringing respiratory products to market and innovative aerosol science, including modelling and toxicology. Presentations will also feature key case studies on the latest trends in inhalation devices, from inhaled insulin to gene therapy to overcome lung and pulmonary conditions, such as COPD, asthma and cystic fibrosis.
Legal and Ethical Issues of International Clinical TrialsWolfgang Kuchinke
An analysis of regulatory, ethical and international aspects of clinical trials is presented, covering all relevant regulatory and ethical requirements for the conduct of international clinical trials. Our analysis is extended by discussing certain legal and ethical issues that are of importance for personalised medicine, especially for the use of software tools dealing with sensitive patient data and supporting patients in their decision making. Following ethical issues connected to the use of personalised medicine tools are discussed:
Tools that have been completely developed and tested for use in a medical environment and are GCP compliant, tools that capture patient data that have to be accurate, reliable and correct. Compliant clinical data management systems (CDMS) that are based on computer system validation. The ethical environment for GCP compliance in data management (audits, subject identification codes, importance of retention of sponsor-specific essential documents). Security of the portal so that unauthorised persons do not have access; the issue of personal data used in clinical trials and “directly" or "indirectly" identifiable data; legal and ethical issues arising by the deep integration of tools for clinical trials in personalised medicine; and issues caused by software that falls under the medical device law. An important aspect is to ensure patient’s autonomy during use of integrated tools for Patient Empowerment.
2017 05-18 Radboudumc Information Management Inspiration Point, Nijmegen, Ala...Alain van Gool
Lecture @ the Inspiration Point of the department Information Management at Radboudumc, to kick-off a discussion with these data specialists the strong needs for good data stewardship and steps that are being taken in Netherlands to organize this well.
Our fifth webinar in the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at how you can determine efficacy in vivo.
Jenny Worthington (Axis Bio)
Presentation - The Economics of the Market for Medicines, Jorge Mestre-Ferran...Office of Health Economics
Jorge Mestre-Ferrandiz also presented a guest lecture at City University, London, on 17 March 2016, on the topic of the economics of the market for medicines.
The first half of the lecture included an overview of the global challenges facing medicines manufacturers, discussion of the ‘supply side’ (focusing on research and development of new drugs), and evidence relating to the ‘demand side’ which suggests that UK spending on medicines as a percentage of GDP is already amongst the lowest in developed countries.
The second half of the lecture looked at NICE and the ‘hurdle’ of demonstrating cost-effectiveness, as well as an overview of pricing regulation, and specific characteristics of the UK market.
With the adoption of EMV bank cards by the US, a strong authN, global identity system is possible, using the payment card network to handle the identity transactions
ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effec...NAMSA
ISO 10993-6 helps identify appropriate implantation sites, how long implants should remain in place during testing, implantation methods and biological responses at the macro- and microscopic level.
Although other departments of the government shall look after market completion, polices etc. BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
Inhalation & Respiratory Drug Delivery SummitDiogo Ribeiro
The IRDD Summit will focus on the challenges of bringing respiratory products to market and innovative aerosol science, including modelling and toxicology. Presentations will also feature key case studies on the latest trends in inhalation devices, from inhaled insulin to gene therapy to overcome lung and pulmonary conditions, such as COPD, asthma and cystic fibrosis.
Legal and Ethical Issues of International Clinical TrialsWolfgang Kuchinke
An analysis of regulatory, ethical and international aspects of clinical trials is presented, covering all relevant regulatory and ethical requirements for the conduct of international clinical trials. Our analysis is extended by discussing certain legal and ethical issues that are of importance for personalised medicine, especially for the use of software tools dealing with sensitive patient data and supporting patients in their decision making. Following ethical issues connected to the use of personalised medicine tools are discussed:
Tools that have been completely developed and tested for use in a medical environment and are GCP compliant, tools that capture patient data that have to be accurate, reliable and correct. Compliant clinical data management systems (CDMS) that are based on computer system validation. The ethical environment for GCP compliance in data management (audits, subject identification codes, importance of retention of sponsor-specific essential documents). Security of the portal so that unauthorised persons do not have access; the issue of personal data used in clinical trials and “directly" or "indirectly" identifiable data; legal and ethical issues arising by the deep integration of tools for clinical trials in personalised medicine; and issues caused by software that falls under the medical device law. An important aspect is to ensure patient’s autonomy during use of integrated tools for Patient Empowerment.
2017 05-18 Radboudumc Information Management Inspiration Point, Nijmegen, Ala...Alain van Gool
Lecture @ the Inspiration Point of the department Information Management at Radboudumc, to kick-off a discussion with these data specialists the strong needs for good data stewardship and steps that are being taken in Netherlands to organize this well.
Our fifth webinar in the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at how you can determine efficacy in vivo.
Jenny Worthington (Axis Bio)
Presentation - The Economics of the Market for Medicines, Jorge Mestre-Ferran...Office of Health Economics
Jorge Mestre-Ferrandiz also presented a guest lecture at City University, London, on 17 March 2016, on the topic of the economics of the market for medicines.
The first half of the lecture included an overview of the global challenges facing medicines manufacturers, discussion of the ‘supply side’ (focusing on research and development of new drugs), and evidence relating to the ‘demand side’ which suggests that UK spending on medicines as a percentage of GDP is already amongst the lowest in developed countries.
The second half of the lecture looked at NICE and the ‘hurdle’ of demonstrating cost-effectiveness, as well as an overview of pricing regulation, and specific characteristics of the UK market.
With the adoption of EMV bank cards by the US, a strong authN, global identity system is possible, using the payment card network to handle the identity transactions
slide set with preliminary notes as i build a public learning and teaching philosophy statement using non-traditional modes of delivery - as promised to students in a Teaching in Higher Ed course that I would make emergent document public. This is the penultimate draft - ready for final scripting.
בשנת 2014 (אומדן מוקדם)
• ההוצאה הלאומית לחינוך הסתכמה ב-86.4 מיליארד ש"ח שהם 7.9% מהתוצר המקומי הגולמי, בדומה לשנת 2013. ההוצאה עלתה ב-1.7%, במחירים קבועים, לעומת שנת 2013, בהמשך לעלייה של 5.9% בשנה הקודמת.
• בהוצאה הלאומית לחינוך לנפש חלה ירידה של 0.2% (במחירים קבועים), בשונה מ-2013 ו-2012 שבהן חלה עלייה של 3.9% ושל 2.5%, בהתאמה.
• משקי הבית מימנו 21.4% מההוצאה הלאומית לחינוך לעומת 20.4% בשנת 2013.
• ההוצאה השוטפת לתלמיד עולה עם העלייה בדרג החינוך; בשנים 2012-2010, עלות לימודיו של תלמיד בחינוך גבוה גדולה יותר מפי שניים מעלות לימודיו של תלמיד בחינוך העל-יסודי, ויותר מפי שלושה מהעלות של תלמיד בחינוך הקדם-יסודי.
October 20, 2010 at the Virginia State Capitol
The Art of Pro Bono, presented by Bob Tarren, Virginia Museum of Fine Arts
Summary: Stretching a dollar is just as important as ever, especially for non-profits. Learn how the VMFA used private partners to make every dollar feel like three.
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
Basic laboratory procedures in clinical bacteriologyamin beni
book of Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology
2020 09-07 European Center Pharmaceutical Medicine course Biomarkers, Basel, ...Alain van Gool
Tutorial lecture on biomarkers for pharmaceutical industry R&D professionals, outlining status, potential and challenges of biomarkers in pharma, clinic and society.
National OncoVenture (NOV) is a Korean government funded oncology drug development program. We are focusing on non-clinical and early stage clinical development of promising oncology drug candidates. These candidates are provided by researchers in academics, research institutes, biotech and pharmaceutical companies. We are co-developing the compounds with the originators through a virtual development model. The majority of the development activities are outsourced to domestic and global CRO/CMOs as well as specialized laboratories throughout the world. During the pre-clinical and clinical development, we aim to improve the value of our candidates by out-licensing our development programs to global pharmaceutical companies who can develop them further for the global market.
2020 02-10 European Center Pharmaceutical Medicine course - biomarkers, Basel...Alain van Gool
Review of biomarkers in personalized healthcare covering pharmaceutical drug development, translational clinical research, digital biomarkers and innovation gaps. This lecture was given as part of an advanced and fantastic pharmaceutical sciences course provided by ECPM.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea
Similar to 4 th Jerusalem Conference on Quality and Pharma Sciences (20)
הטמפרטורה העולמית הממוצעת היא הפרמטר המופיע ברוב הגרפים המתארים את השתנות הטמפרטורה עם הזמן.
גרפים אלה מוצגים כדי להציג בפני קהל הקוראים והשומעים את המגמה העולה של הטמפרטורה הממוצעת העולמית.
בדיון על גרפים אלה לא מציינים בפני הקוראים שתי עובדות חשובות:
האחת כל "בנקי הנתונים" בעולם מתקנים את הנתונים שנמדדו, לדוגמה הגרף הבא מציג את נתוני הטמפרטורה לפני התיקון ואחריו.
2022 marks the 6th year in which the Israeli Atlas Award event will be held in cooperation with the Ayn Rand Center, TheMarker and other leading partners such as the Prometheus foundation, Dow Gr. and Karyopharm Therapeutics. The prize will be granted to the Israeli start-up company which created a new technology, idea or product of exceptional value in Israel and worldwide.
יום ראשון השבוע אזל החשמל בישראל. ככה. כמו שקראתם. כושר הייצור פשוט מוצה. תחנות הכוח שלנו הגיעו לקצה יכולתן.
לכן, בשעה 13:00 קיבלו צרכני חשמל גדולים הודעה שלפיה אם למשך ארבע שעות, בין 17:30 ל-21:30, יואילו בטובם להתנתק מהרשת ולא לצרוך חשמל — הם יקבלו בתמורה סכום נדיב למדי. עד פי 15 מעלות החשמל שהיו צורכים, היישר לכיס. דיל לא רע. "השלה מרצון" שמו.
Techniques to optimize the pagerank algorithm usually fall in two categories. One is to try reducing the work per iteration, and the other is to try reducing the number of iterations. These goals are often at odds with one another. Skipping computation on vertices which have already converged has the potential to save iteration time. Skipping in-identical vertices, with the same in-links, helps reduce duplicate computations and thus could help reduce iteration time. Road networks often have chains which can be short-circuited before pagerank computation to improve performance. Final ranks of chain nodes can be easily calculated. This could reduce both the iteration time, and the number of iterations. If a graph has no dangling nodes, pagerank of each strongly connected component can be computed in topological order. This could help reduce the iteration time, no. of iterations, and also enable multi-iteration concurrency in pagerank computation. The combination of all of the above methods is the STICD algorithm. [sticd] For dynamic graphs, unchanged components whose ranks are unaffected can be skipped altogether.
Show drafts
volume_up
Empowering the Data Analytics Ecosystem: A Laser Focus on Value
The data analytics ecosystem thrives when every component functions at its peak, unlocking the true potential of data. Here's a laser focus on key areas for an empowered ecosystem:
1. Democratize Access, Not Data:
Granular Access Controls: Provide users with self-service tools tailored to their specific needs, preventing data overload and misuse.
Data Catalogs: Implement robust data catalogs for easy discovery and understanding of available data sources.
2. Foster Collaboration with Clear Roles:
Data Mesh Architecture: Break down data silos by creating a distributed data ownership model with clear ownership and responsibilities.
Collaborative Workspaces: Utilize interactive platforms where data scientists, analysts, and domain experts can work seamlessly together.
3. Leverage Advanced Analytics Strategically:
AI-powered Automation: Automate repetitive tasks like data cleaning and feature engineering, freeing up data talent for higher-level analysis.
Right-Tool Selection: Strategically choose the most effective advanced analytics techniques (e.g., AI, ML) based on specific business problems.
4. Prioritize Data Quality with Automation:
Automated Data Validation: Implement automated data quality checks to identify and rectify errors at the source, minimizing downstream issues.
Data Lineage Tracking: Track the flow of data throughout the ecosystem, ensuring transparency and facilitating root cause analysis for errors.
5. Cultivate a Data-Driven Mindset:
Metrics-Driven Performance Management: Align KPIs and performance metrics with data-driven insights to ensure actionable decision making.
Data Storytelling Workshops: Equip stakeholders with the skills to translate complex data findings into compelling narratives that drive action.
Benefits of a Precise Ecosystem:
Sharpened Focus: Precise access and clear roles ensure everyone works with the most relevant data, maximizing efficiency.
Actionable Insights: Strategic analytics and automated quality checks lead to more reliable and actionable data insights.
Continuous Improvement: Data-driven performance management fosters a culture of learning and continuous improvement.
Sustainable Growth: Empowered by data, organizations can make informed decisions to drive sustainable growth and innovation.
By focusing on these precise actions, organizations can create an empowered data analytics ecosystem that delivers real value by driving data-driven decisions and maximizing the return on their data investment.
4 th Jerusalem Conference on Quality and Pharma Sciences
1. - 1 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
4th
Jerusalem
Conference
on
Quality
and
Pharma
Sciences
A
unique
podium
for
highlighting
applications
of
quality
by
design
(QbD)
to
the
Pharma
Sciences
May
20-‐22nd
,
2014
Belgium
House
(www.bb.huji.ac.il),
The
Edmond
Safra
Campus
The
Hebrew
University
of
Jerusalem
Conference
direct
e-‐mail:
pharmacy@ekmd.huji.ac.il
http://ce.pharmacy.wisc.edu/mod/coursepage/view.php?id=4008
Sponsors
The
School
of
Pharmacy
Institute
for
Drug
Research,
The
Hebrew
University
of
Jerusalem,
Israel
University
of
Wisconsin,
Madison,
School
of
Pharmacy,
USA
Teva
Pharmaceutical
Industries,
Israel
Perrigo
USA,
Perrigo
Israel.
Sol-‐Gel
Technologies
Ltd,
Israel
The
David
R.
Bloom
center
of
Pharmacy
of
the
Hebrew
University
of
Jerusalem
ENBIS,
the
European
Network
for
Business
and
Industrial
Statistics
KPA,
Israel
JMP,
Statistical
Discovery
from
SAS,
USA
Organizing
and
Scientific
Committee
• Prof.
Ron
Kenett,
Hebrew
University,
School
of
Pharmacy,
The
University
of
Turin,
The
NYU
Center
for
Risk
Engineering
and
KPA
Ltd.
ron@kpa-‐group.com
• Prof.
Philip
Lazarovici,
The
Institute
for
Drug
Research,
School
of
Pharmacy,
The
Hebrew
University
of
Jerusalem.
philipl@ekmd.huji.ac.il
• Louis
W.
Yu,
Ph.D.
Executive
Vice
President,
Global
Quality
&
Compliance,
Perrigo.
louis.yu@perrigo.com
• Prof.
Melvin
Weinswig,
School
of
Pharmacy
University
of
Wisconsin,
Madison.
mhweinswig@pharmacy.wisc.edu
• Prof.
Jean-‐Paul
Lellouche,
Department
of
Chemistry,
Nanomaterial
Research
Center,
Institute
of
Nanotechnology
&
Advanced
Materials,
Bar-‐Ilan
University.
lellouj@biu.ac.il
• Esther
Urkin,
Perrigo
Israel.
esther.urkin@perrigo.co.il
• Dr.
Yafit
Stark,
Teva
Pharmaceutical
Industries,
yafit.stark@teva.co.il
• Prof.
Alan
Hanson,
School
of
Pharmacy
University
of
Wisconsin,
Madison.
alhanson@pharmacy.wisc.edu
• Inna
Ben-‐Anat,
Teva
Pharmaceutical
Industries,
Inna.Ben-‐Anat@tevapharm.com
• Prof.
David
Steinberg,
Tel
Aviv
University,
President
of
the
Israel
Statistical
Association
dms@post.tau.ac.il
• Prof.
Avri
Rubinstein,
The
Institute
for
Drug
Research,
School
of
Pharmacy,
The
Hebrew
University
of
Jerusalem.
avrir@ekmd.huji.ac.il
• Eldad
Yoffe,
Administrative
Manager,
The
Institute
for
Drug
Research,
School
of
Pharmacy,
The
Hebrew
University
of
Jerusalem.
eldadj@savion.huji.ac.il
2. - 2 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
PROGRAM
Day 1: May 20th
, 2014
8:30 Registration
9:00 Opening: Prof. Simon Benita, Head School of Pharmacy Institute for
Drug Research
9:10 Keynote: Attaining and Sustaining Pharmaceutical Product
Quality - A Quality Culture Approach
Louis W. Yu, Ph.D. Executive V.P. Quality Control, Perrigo
1. A Pharmaceutical Quality
Chairperson: TBD
9:50 (2) A2 Sustaining Quality Compliance - Strategies to arrest
"drifting from good"
Claudio Pincus, President of the Quantic Group, USA
10:20 (3) A3 Pharmaceutical Quality and Clinical Research Quality:
The interaction
Dr. Yafit Stark, Teva, Israel
10:40 Coffee Break
2. B Analytical Methods
Chairperson: TBD
11:00 (1) B1 Analytical Method Development - A Life Cycle Quality by
Design
Rosario LoBrutto, Sr. Director, Head of Research and
Development (Parenterals), TEVA Pharmaceuticals, Pomona,
New York, USA
11:30 (2) B2 Estimation of Uncertainty of Analytical Methods
From Validation Data in the Pharmaceutical QC Lab
Raphael Bar, Ph.D., BR Consulting, Israel
12:00 (3) B3 Statistical Models for GR&R (Gauge Repeatability and
Reproducibility) Studies
Professor David Steinberg, Tel Aviv University, Israel
.
12:30 Lunch
3. - 3 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
3. C DOE and QbD in Pharmaceutical Research
Chairperson: TBD
14:00 (1) C1 A Design of Experiments (DoE) Approach to Optimized
Fabrication of Magnetic Maghemite Nanoparticles for Imaging
and Gene Silencing
Professor J-P. Lellouche, Bar Ilan University, Israel
14:30 (2) C2 QbD in Liposome Development
Professor Yechezkel (Chezy) Barenholz, Hebrew University,
Medical School, Jerusalem, Israel
15:00 (3) C3 Definitive Screening Designs
Ian Cox, JMP Division of SAS
15:30 Special Invited Speaker - TBD
16:30 Q&A Session – Moderator: Prof Mel Weinswig
17:30 Day 1 closure
18:00 Conference Dinner
Day 2: May 21st
, 2014
8:30 Registration
9:00 Keynote: Rapid Screening Methods for FDA Pharmaceutical
Surveillance
Dr. Lucinda (Cindy) Buhse, Director, FDA Division of Pharmaceutical
Analysis, FDA St. Louis, USA
4. D Regulatory Updates and the use of data
Chairperson: Louis W. Yu, Ph.D. Executive V.P. Quality Control, Perrigo
9:40 (1) D1 Pharmacovigilance in Israel-The Way Forward
Grainne Quinn, M.D., VP, Global Head of Patient Safety, Perrigo
10:10 (2) D2 Pre-competitive gains from data sharing across sponsors: the
power of big data and collaboration
Professor Jonathan Rabinowitz, Bar Ilan University, Israel
10:40 (3) D3 International Quality Operations: Approaches to Quality
Metrics and Continuous Improvement
Stacy Berkshire, Perrigo
4. - 4 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
11:10 Coffee Break with light meal
5. E QbD in Pharmaceutical Development
Chairperson: TBD
12:00 (1) E1 Applications of non-standard DOE in QbD
Inna Ben-Anat,Teva
12:30 (2) E2 QbD development of topical products
Michal Arnon, Perrigo
13:00 (3) E3 QbD in developing semisolid formulations
Haim Barsimantov, COO, Sol-Gel
6. F Quality Challenges in 2020 Drug Products
13:30 Panel – Moderator: Prof Philip Lazarovici
Dr. Yafit Stark, Teva
Prof. Louis Yu, Perrigo
Prof. Mel Weinswig, UW, USA
Prof. Ron Kenett, KPA, Hebrew Univ. and Univ of Turin
Rosario LoBrutto, Research and Development (Parenterals),
TEVA Pharmaceuticals, USA
Dr. Lucinda Buhse, FDA Central Laboratories, USA
Claudio Pincus, Quantic Group, USA
14:30 Day 2 closure
5. - 5 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
Day 3: May 22nd
, 2014
A Special Introductory Workshop on:
Statistical Tools Supporting the New Process Validation Guidelines
Presenters: Prof Ron Kenett and Prof David Steinberg
The FDA new Process Validation Guidelines cover 3 stages in the lifecycle of the
product. The first phase is the design of the product and production process, the
second phase is qualification of the process and the third phase is ongoing
monitoring of the process. The January 2011 guidelines on process validation offer
new possibilities and challenges and require the application of various statistical
methods. The new approach is scientific based and builds on all quality by design
guidelines. The guideline is driving industry to move from an inspection focus, where
things are inspected and the output of an inspection is pass/fail, to a deeper
understanding and a more in-depth analysis of what is going on. The three stages
and the corresponding main statistical tools supporting them are listed below.
Stage 1: Process Design; Development through submission – Statistical Design of
Experiments (DOE).
Stage 2: Process Qualification; Submission through launch - Acceptance
Sampling Plans
Stage 3: Continued Process Verification; During the commercial manufacturing of
the product – Statistical Process Control (SPC).
This introductory workshop is designed to provide participants with a guided tour
through the statistical design of experiments (DOE), acceptance sampling and
statistical; process control (SPC).
The material presented in the workshop is based on the second edition of:
Modern Industrial Statistics with applications in R, MINITAB and JMP by Kenett and
Zacks, Wiley 2014 (http://eu.wiley.com/WileyCDA/WileyTitle/productCd-
1118456068.html. Real life examples and simulations will be provided using JMP.
Workshop agenda:
9:00 Introduction to QbD and the New Process Validation Guideline
9:30 Design of Experiments (DOE)
11:15 Coffee Break
11:45 Acceptance Sampling
14:00 Lunch Break
14:45 Statistical Process Control (SPC)
16:30 Closure
7. - 7 -
The Hebrew University of Jerusalem
The School of Pharmacy Institute for Drug Research
The 4rd
Jerusalem Conference on Quality and Pharma Sciences
20-21
st
May, 2014 at the Hebrew University of Jerusalem,
Edmond J. Safra Campus, Givat Ram
Conference participation fees, per person: 500 ₪ (student 250 ₪); Single day: 350 ₪
Participation in the special workshop on 22/5 is free but requires pre-registration
Please print the form, fill it in and fax to 02-675-7252 or scan and send to:
mador@ekmd.huji.ac.il
_____________________________________________________________________
To: The School of Pharmacy, The University of Jerusalem
First Name:_______________________ Family Name:________________________
Personal ID number: |__|__|__|__|__|__|__|__|__|
Address:_____________________________________________________________
Telephone: ___________________Email: __________________________________
Job and Place of Work: ______________________Work Phone:________________
Please register me to the special workshop on 22/5/2014.
Payment Information (please print clearly):
Payment by credit card in the amount of: _________________
Isracard |_| Mastercard |_| Am. Express |_| Visa Leumi |_| Visa Cal |_| Diners |_|
|__|__|__|__|__|__|__|__|__|__|__|__|__|__|__|__| |__|__|__|__| ___________
Card Number Expiry date Card Holder
|__|__|__|__|__|__|__|__|__|__| Signature:______________________________
Personal ID number of card holder
Payment by check in the amount of: __________ to be made out to the Hebrew University
of Jerusalem
Payment by bank transfer by Company/ Commitment form
Receipt number (office use only):_____________________