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מנוי

Regulatory Affairs

Home :: All Courses Number of Courses: 120

Upcoming

2018

26/11/2018
1 - Day Course
ICH E6(R2)
Key Changes, Implementation and Being Prepared to Address Inspection Questions

Lecturer: Ms. Penelope Przekop
 
27/11/2018
1 - Day Course
EU GDPR
How it Impacts Pharmaceutical Companies and How to Ensure Compliance

Lecturer: Ms. Penelope Przekop
 
29/11/2018
1 - Day Course
FDA REMS
Risk Evaluation and Mitigation Strategies Program

Lecturer: Ms. Penelope Przekop
 
12/12/2018
1 - Day Course
Physical Properties Characterization of Pharmaceutical Powders
Lecturer: Dr. Judith Aronhime
 
27/12/2018
1 - Day Course
אמ"ר משולב ענן IoMT
Lecturer: Mr. Guy Vinograd
 

2019

07/01/2019
1 - Day Course
יישום שלמות הנתונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
09/01/2019
1 - Day Course
Impurities in APIs and Pharmaceutical Products
Current Regulatory Requirements

Lecturer: Dr. Rachel Karpel
 
15/01/2019
1 - Day Course
Annex 11 & Part 11
Lecturer: Mr. Mike Zeevi
  Computerized Systems, Electronic Records and Electronic Signatures — Scope and Application
18/02/2019
1 - Day Course
Medical Devices
Implementation of the New Requirements of Health Canada

Lecturers: Dr. Valentin Fulga, Ms. Netta Fulga
 
25/02/2019
2 - Day Course
Inspections and audits in Pharmacovigilance


Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
25/03/2019
2 - Day Course
מבדקי אמ"ר
Lecturer: Ms. Iris Leinwand
 
04/04/2019
1 - Day Course
Batch Release
Lecturer: Dr. Rachel Karpel
 
14/05/2019
1 - Day Course
קורס מרוכז לכתיבת פרוטוקול ודוח מסכם
Lecturer: Dr. Shiri Diskin
 
27/05/2019
1 - Day Course
QSR for pharma
Lecturer: Mr. Eran Yona
 

TBA

TBA
1 - Day Course
התקן הישראלי החדש לענף הקוסמטיקה
Lecturer: Dr. Rachel Karpel
 
TBA
1 - Day Course
דרישות רגולטוריות בתחום הגזים רפואיים
Lecturer: Ms. Ronit Sade
 
TBA
1 - Day Course
אבקות ב- USP והטמעה של PAT
Lecturer: Mrs. Marta Lichtig
 
TBA
2 - Day Course
From collection to reporting processing your safety cases in clinical trials and post marketing
Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
TBA
2 - Day Course
Registration of Generic Drugs in the US
Lecturer: Mrs. Dalit Fuchs
 
TBA
1 - Day Course
בקרת מזיקים בתעשייה
Lecturer: Mr. אלי לוגסי
 
TBA
2 - Day Course
Regulation of Combination Products
Lecturer: Dr. Hagit Marchaim, Dr. Sara Horn
 
TBA
1 - Day Course
גידול צמחי קנאביס רפואי בתנאים נאותים
Lecturer: Mr. Eran Yona
 
TBA
1 - Day Course
Advanced research in pathology;
a key for a successful pre-clinical study.

Lecturers: Mr. Emmanuel Lub
 
TBA
1 - Day Course
יצור בתנאי GMP של קנאביס רפואי
Lecturers: Dr. Rachel Karpel
 
TBA
1 - Day Course
Transfer of Analytical Procedures
As part of Product Life Cycle

Lecturer: Ms. Maria Rubin
 

Past Activities

2018

12/11/2018
1 - Day Course
נוהל 126:תנאי אחסון והובלה של תכשירים
Lecturer: Dr. Sigalit Arieli-Portnoy
 
31/10/2018
1 - Day Course
Risk Management Workshop
Lecturer: Ms. Bosmat Friedman, Ms. Shoshana Friedman
 
24/10/2018
1 - Day Course
Implantation of GMP in the manufacturing of Cell Therapy and Stem Cells
Lecturer: Dr. Sigalit Arieli-Portnoy
 
24/10/2018
2 - Day Course
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
11/07/2018
1 - Day Course
Environmental Monitoring
Lecturer: Ms. Karen Ginsbury
 
11/07/2018
2 - Day Course
ולידציה לתהליכי ניקיון- מהלכה למעשה
Lecturer: Mr. Eran Yona
 
02/07/2018
1 - Day Course
רישום תמרוקים
Lecturer: Ms. Gali Amir (B.Sc. M.Sc)
 
29/05/2018
2 - Day Course
From MDD to EU MDR
Lecturers: Mr. Robert Van Boxtel
 
09/05/2018
1 - Day Course
GMP/GDP Updates
Lecturer: Ms. Karen Ginsbury
 
30/04/2018
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
15/03/2018
1 - Day Course
The Pre-Submission Program
and Meetings with FDA Staff

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
14/03/2018
1 - Day Course
Clinical Trials with Medical Device
From Design to Final Report

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
01/02/2018
1 - Day Course
עריכת מבדקי ספקים
Lecturers: Ms. Yafit Toledano
 

2017

20/11/2017
2 - Day Course
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
18/09/2017
1 - Day Course
Customer Complaints, Vigilance Reporting and Post Market Surveillance
Lecturer: Mr. Gadi Shtepel
 
06/09/2017
1 - Day Course
ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability
Lecturer: Dr. Rachel Karpel
 
09/07/2017
2 - Day Course
Risk Management Plan
are you in compliance with the new Israeli regulation?

Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
28/06/2017
1 - Day Course
נוהל 126:תנאי אחסון והובלה של תכשירים
Lecturer: Dr. Sigalit Arieli-Portnoy
 
06/06/2017
1 - Day Course
Conducting Effective Internal Pharmaceutical Compliance Audits
Lecturer: Ms. Karen Ginsbury
 
05/06/2017
1 - Day Course
Advanced pathological methods for the pre-clinical phase of your product development
Lecturers: Mr. Emmanuel Lub
 
17/05/2017
1 - Day Course
Annex 11 & Part 11
Lecturer: Mr. Mike Zeevi
  Computerized Systems, Electronic Records and Electronic Signatures — Scope and Application
17/05/2017
1 - Day Course
ProMedoss Event 2017
:
 
04/05/2017
1 - Day Course
אחריות מנהלים בחברת מדעי החיים
Lecturers: Ms. Shiri Diskin
 
26/04/2017
1 - Day Course
נוהל 129
Lecturers: Ms. Yafit Toledano
 
04/04/2017
1 - Day Course
Batch Release
Lecturer: Dr. Rachel Karpel
 
28/03/2017
1 - Day Course
יצור בתנאי GMP של קנאביס רפואי
Lecturers: Dr. Rachel Karpel
 
15/03/2017
1 - Day Course
FDA Update: New Requirements, Trends and Guides
Lecturer: Ms. Shoshana Friedman
 
06/03/2017
1 - Day Course
Getting FDA Clearance/Approval for Medical Devices
What, When and How?

Lecturer: Ms. Shoshana Friedman
 
13/02/2017
1 - Day Course
Data Focus:
Protocol and Data Management – Key Elements in Clinical Trials

Lecturers: Ms. Irina Sher, Dr. Shiri Diskin
 

2016

29/12/2016
1 - Day Course
Patient Centric
Lecturers: Gerald Finken, Joe Martinez
 
29/12/2016
1 - Day Course
IMP Noon-Seminar - Direct-to-Patient
Lecturers: Gerald Finken, Joe Martinez, Mr. Philippe Van der Hofstadt Hofstadt
 
13/12/2016
2 - Day Course
ISO 13485:2016 and EU MDR
Lecturers: Mr. Robert van Boxtel, Ms. Veronick Jasner
 
04/12/2016
1 - Day Course
Deviations, Investigations, CAPA
and ISO9001:2015

Lecturer: Ms. Karen Ginsbury
 
28/11/2016
1 - Day Course
Color Testing
Lecturer: Dr. Yehuda Shekel
 
07/11/2016
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
02/11/2016
1 - Day Course
Physical Properties Characterization of Pharmaceutical Powders
Lecturer: Dr. Judith Aronhime
 
03/05/2016
1 - Day Course
EU Technical File
How to Prepare and Submit

Lecturer: Dr. Raanan Aloni
 
16/02/2016
2 - Day Course
Cosmetic Products Regulations in Israel and the European Union
Lecturer: Dr. Annelie Struessmann, Mgr. Rinat Baker, Mr. Steven L. Hanft
 
01/02/2016
1 - Day Course
FDA Regulatory Updates in Medical Device
Lecturer: Ms. Sarit Gelbert
 

2015

06/07/2015
1 - Day Course
Cleaning Validation
Lecturer: Ms. Karen Ginsbury
 
21/01/2015
1 - Day Course
Workshop: Full Processing of Adverse Reactions/Adverse Events Reports
Lecturers: Mr. Gal Friedman, Dr. Irene Fermont
 

2014

15/09/2014
2 - Day Course
Registration of Generic Drugs in the US
Lecturer: Mrs. Dalit Fuchs
 
09/07/2014
1 - Day Course
Conducting Effective Investigations
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
24/06/2014
2 - Day Course
EU Good Pharmacovigilance Practices : the guidelines for all your key processes
Lecturer: Dr. Irene Fermont, France
 

2013

25/11/2013
1 - Day Course
Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
  To review the purpose of SOPs and to provide participants with tools to write their own SOPs that are clear, concise and not open to interpretation. The course will include group exercises and participants will take home an SOP that they have prepared
16/10/2013
1 - Day Course
System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
  Including case-studies, handling deviations (+ a sneak peep at the FDA Process Validation Draft)
17/07/2013
2 - Day Course
Roles, Responsibilities & Activities of the QP in Europe and in Israel
Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
 
24/06/2013
1/2 - Day Course
עדכוני GDP - GOOD DISTRIBUTION PRACTICE
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
28/05/2013
1 - Day Course
Preparing For and Passing an FDA Inspection
Lecturer: Mr. Michael Anisfeld, USA
 
07/03/2013
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
27/02/2013
1 - Day Course
Polymorphism in the Pharmaceutical Industry
Lecturer: Dr. Judith Aronhime
 
15/01/2013
1 - Day Course
התקן הישראלי החדש לענף הקוסמטיקה
Lecturer: Dr. Rachel Karpel
 

2012

13/11/2012
1 - Day Course
ICH Q11 Guidance on: Development and Manufacture of Drug Substances
Lecturers: Ms. Karen Ginsbury
  ICH Q11 Guidance on: Development and Manufacture of Drug Substances
07/11/2012
1 - Day Course
The FDA 505 (b) (2) Drug Approval Process
Lecturer: Ken Phelps, President and CEO, Camargo Pharmaceutical Services, USA
  Reduce cost and timelines by using Strategy, Commercial and Regulatory aspects
22/07/2012
2 - Day Course
Analytical Data at the Service of the Regulatory, Formulation and QA Staff
Lecturer: Dr. Malcolm Ross, Switzerland
 
17/05/2012
1 - Day Course
Phase Appropriate GMP for Investigational Products
Lecturer: Ms. Karen Ginsbury
 
15/05/2012
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
02/05/2012
1 - Day Course
Clinical Batch Release
Lecturer: Mrs. Sue Mann, UK
  the Roles, Responsibilities and Activities of the EU Qualified Person
17/01/2012
1 - Day Course
A Beginners Practical Guide to Medical Device Regulations
Lecturer: Dr. Judah Lando
 

2011

27/07/2011
1 - Day Course
Regulatory Intelligence (RI)
Lecturer: Mr. Daniel Albahari
 
01/06/2011
2 - Day Course
Marketing Authorization of Biologicals in the EU
Lecturer: Dr. Barbara Jentges
  This course focuses on the legislative environment regulating biologicals within the European Union and gives an understanding of the regulatory steps that need to be taken to successfully place a biological on the European market.
13/04/2011
1 - Day Course
The European Variations Rules & the Science Behind
Lecturer: Dr. Malcolm Ross, Switzerland
  This one day course is designed to address those changes which are related to product and production rather than the administrative changes that are related to labeling or change of address etc. This discusses variations from both the regulatory and the technical side and is designed to provide a deeper understanding of the technical process involved for regulatory and registration officers.
06/03/2011
2 - Day Course
Building eCTD-compliant Documents and Preparing an eCTD Submission
Lecturer: Dr. Barbara Jentges
  This course will give an understanding for ‘eCTD’ and the differing regional requirements. Aspects for the preparation of ‘eCTD-compliant’ documents will be discussed in detail during practical examples.
26/01/2011
2 - Day Course
MedDRA® : A Comprehensive Training Course
Lecturer: Dr. Elliot Brown, UK
 
25/01/2011
1 - Day Course
Israeli Legislation on the Quality of Drugs and Biologics
Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
 

2010

25/10/2010
3 - Day Course
GDP - תנאי הפצה נאותים
Professional management: Mgr. Efrat Strugo
 
21/07/2010
2 - Day Course
European Drug Regulatory Affairs: Strategy and Practice with European Regulatory Procedures
Lecturer: Dr. David Jacobs, Switzerland
 
16/06/2010
2 - Day Course
Development of Combination Products - Regulatory & Clinical Considerations
Lecturer: Dr. Barbara Fant
 
15/06/2010
1/2 - Day Course
When Safety Meets Regulation
Lecturers: Dr. Barbara Fant, Dr Irene Fermont
 
09/03/2010
6 - Day Course
RA Managers in the Biomed Industry
Professional management: Ms. Yehudith Wexler
  The biomedical industries - pharmaceuticals, biotechnology, medical devices - have to meet the requirements of the health authorities in order to distribute and market their products.
21/02/2010
Meeting
Medical Device Companies
Lecturer: Mr. Clay Anselmo
  This course will give an overview on worldwide regulatory frameworks, discussing how to develop Regulatory and QMS strategies to meet the business needs.
15/02/2010
2 - Day Course
Pharmacovigilance - basic level
Lecturer: Dr. Irene Fermont
 
19/01/2010
1 - Day Course
GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
  Isranalytica 2010 – Related Events

2009

12/11/2009
1 - Day Course
Liposome Applications
Professional management: Dr. Doron Friedman
  This comprehensive course is designed to bring together several aspects of the subject. This includes design, fabrication and basic science which are all critical to the above including physics and chemistry and clinical development, toxicology aspects, case studies and I.P. issues.
22/06/2009
6 - Day Course
Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics
Professional management: Mgr. Efrat Strugo
 
26/05/2009
1 - Day Course
Quality Product Review
Lecturer: Ms. Karen Ginsbury
  This one day course will take an in depth look at the regulatory requirements (EU and FDA) for performing quality reviews in the context of Q10 – Pharmaceutical Quality System Guidance which requires Management Review and ongoing product and process performance monitoring, as well in the light of the draft FDA guidance on Process Validation that requires ongoing process verification. Product Annual Review as performed by companies to-date will be a large part of the quality review but this course will review those additional elements that are required in order to remain current with updated regulations and expectations.
25/05/2009
2 - Day Course
Managing Extractables and Leachables in Pharmaceutical Products
Lecturer: Ph.D. Edward J. Smith
  This course will review guidance documents, and other regulations regarding the identification, measurement, toxicological qualification, and reporting of extractables/leachables from packaging and process materials into pharmaceutical and biotech products. Included in the course is a detailed discussion of the sources of extractables from glass, rubber, and plastic packaging and process components and the work of the Product Quality Research Institute (PQRI) on inhalation, ophthalmic, and parenteral products. Examples will also be presented to demonstrate how E&L issues can be mitigated through the judicious choice of packaging components and materials.
11/02/2009
1 - Day Course
Risk Management Strategy Planning
Lecturer: Dr. Malcolm Ross, Switzerland
  Although risk management in the industry is not new, recently the Regulatory Authorities are making it a formal requirement through such initiatives as ICH Q9 [Quality Risk Management] and the FDA’s Risk Evaluation and Mitigation Strategy for new drugs.

2008

04/11/2008
2 - Day Course
CMC Submissions in the CTD Format
Lecturer: Carolyn H. Kruse, USA
  This course will address the regional requirements and the differences in approaches to document review for the three ICH territories: US, EU and Japan. This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and other Regulatory Authorities for the new drug applications (NDA’s).

2006

09/03/2006
1 - Day Course
Compliance and Passing Inspections
Lecturer: Karen Ginsbury
 
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