Regulatory Affairs

Upcoming

2011

TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
TBA 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.
TBA Day Course	Introduction to Bioassay for Non-Biologists Lecturer: Dr. Ana Menendez, USA
22/05/2011 3 - Day Course	Role, Responsibilities and Activities of the Qualified Person in the European Union Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
25/05/2011 Day Course	The Role of the Qualified Person (QP) of Pharmaceutical and Veterinary Manufacturers and Importers in Israel Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
26/05/2011 Day Course	Writing and Understanding Technical Agreements Lecturers: Dr Christopher Burgess, Mr. Richard Bonner

2010

14/09/2010 Day Course	Color Testing Lecturer: Dr. Yehuda Shekel
06/10/2010 Day Course	Product Lifecycle and Product Control Strategy - ICH Q8, Q9, Q10 Lecturer: Ms. Karen Ginsbury
	This one day seminar will take a novel look at product and process development through marketing in the light of the newest ICH guidances. A product control strategy and a lifecycle approach to product and process management are regulatory requirements – the EU is in the process of updating Chapter 1 of the EU GMPs to incorporateICH Q10 Pharmaceutical Quality System. ICH Q9 and the principles of Risk Management are already incorporated.
20/10/2010 Day Course	GMPs for Printed Packaging Materials Lecturer: Ms. Karen Ginsbury
	The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and / or of product recall because of packaging or labeling mix-ups.
25/10/2010 3 - Day Course	GDP - תנאי הפצה נאותים Professional management: Mgr. Efrat Strugo
02/11/2010 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
02/11/2010 Day Course	בדיקת אנדוטוקסינים בתרופות ואביזרים רפואיים (אמ"ר) המוזרקים / מושתלים בגוף Lecturer: Mr. Eliezer Solomon
03/11/2010 Day Course	Product Quality Review as a Tool for Continued Process Verification Lecturer: Ms. Karen Ginsbury
07/11/2010 2 Meetings	Regulatory Affairs and Quality for Managers Lecturer: Rivka Zaibel
08/11/2010 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.
10/11/2010 Day Course	Extractables and Leachables from containers/closures of drugs and from devices Lecturer: Dr. Raphy Bar
	This course will give participants an understanding of how chemicals leached from containers and closures of pharmaceutical and biopharmaceutical drugs as well as from medical devices, are detected and quantified in the framework of a properly designed Extractables/Leachables (E&L) study. Examples of E&L will be presented.
10/11/2010 Day Course	Simulation/Mock FDA meeting Preparation Lecturer: Ms. Shoshana Friedman
16/11/2010 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
22/11/2010 2 - Day Course	MedDRA® : A Comprehensive Training Course Lecturer: Dr Elliot Brown
24/11/2010 Day Course	Analytical Standards in Pharmaceutical & Bio-pharmaceutical Laboratories: Qualification of Primary & Secondary Standard Lecturer: Dr. Raphy Bar
30/11/2010 Day Course	Cleaning Validation Lecturer: Ms. Karen Ginsbury
07/12/2010 Day Course	Good Clinical Practice 2010 - Clinical Trials for Medical Device Lecturer: Dr. Monica Tocchi
13/12/2010 2 - Day Course	Supplier Approval – Managing Risk in Your Supply Chain Lecturer: Ms. Karen Ginsbury
21/12/2010 2 - Day Course	A deep Insight into Pharmacovigilance and Risk Management Regulatory Systems, advanced level Lecturer: Dr. Irene Fermont
22/12/2010 2 - Day Course	Analytical Data Serving the QA, Regulatory & Formulation Staff Lecturer: Dr Malcolm Ross
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.

Past Activities

2010

27/07/2010 Day Course	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products Lecturer: Dr. Rachel Karpel
	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products
21/07/2010 2 - Day Course	European Drug Regulatory Affairs: Strategy and Practice with European Regulatory Procedures Lecturer: Dr. David Jacobs, USA
TBA 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
23/06/2010 3 - Day Course	Regulatory and Quality requirements for the registration of Biologics/Biotechnology Products Lecturer: Rivka Zaibel
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
15/06/2010 Day Course	When Safety Meets Regulation Lecturers: Dr. Barbara Fant, Dr Irene Fermont
TBA Day Course	Clinical Leadership and Governance for Trial Sponsors Lecturer: Dr. Monica Tocchi
26/05/2010 Day Course	System & Equipment Qualification & Validation Lecturer: Ms. Karen Ginsbury
	Every regulatory inspection and customer audit reviews validation qualification files. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) as well as validation protocols and reports are all essential elements of a modern pharmaceutical quality system. This one day course will review the GMP requirements relating to validation, guidelines and regulatory expectations as well as inspectional approaches to this critical topic.
13/05/2010 Day Course	ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability Lecturer: Dr. Rachel Karpel
12/05/2010 Day Course	Analysis & Charaterization of Polymorphs in the Pharmaceutical industry Lecturer: Dr. Judith Aronhime
11/05/2010 Day Course	Regulatory Strategies for Medical Device Lecturer: Ms. Shoshana Friedman
10/05/2010 Day Course	A Beginners Practical Guide to Medical Device Regulations Lecturer: Dr. Judah Lando
TBA Day Course	Quality Aspects in Management of Contract Manufacturers Lecturer: Ms. Karen Ginsbury
29/04/2010 Day Course	Technology Transfer of Analytical Methods Lecturer: Dr. Raphy Bar
	Analytical methods once validated, are often transferred and implemented in other laboratories. Thus, methods can be transferred from an R&D lab to a QC lab in the same or different site, or to an external CRO lab.
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
TBA Meeting	WEEE, RoHS and REACH - Important legal issues for producers of Medical Devices Lecturer: Tina Bao, adv
TBA 4 - Day Course	Quality in Registration Files Lecturer: Dr. Rachel Karpel
22/03/2010 Day Course	The Paperless Laboratory – Regulatory and Computer Aspects of Going Electronic Lecturers: Mr. Alex Krigel, Ms. Daphna Spector-Grossbard
22/03/2010 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking in 2010 Lecturer: Dr. Monica Tocchi
	This course is intended for manufacturers who are planning to bring their devices to the European market and need clinical data to support their product claims according with the new EU Directives, which take effect on March 21, 2010. One key change is the requirement of more clinical data for devices placed on the market in any of the 27 EU member nations. For clinical investigations, there will be more scrutiny of clinical dossiers and communication between authorities, for example, refusal from one country will be shared with all other nations. Devicemakers need practical tools for immediate compliance with the new requirements, that this course will provide.
22/03/2010 Day Course	Conducting, Documenting and Ensuring Effective Investigations Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
	At the end of this course participants will understand how to effectively investigate deviations and untoward events.
17/03/2010 Day Course	The Israeli Regulation for Pharmacology – Updates Lecturers: Mgr. Naomi Shaco Ezra, Adv. Zohar Yahalom
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.
TBA 2 - Day Course	Drug Safety Lecturer: Ms. Orit Neudorfer
	This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan.
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
08/02/2010 Day Course	Change Management According to the Q10 Guidelines Lecturer: Ms. Karen Ginsbury
	This one day, intensive course will address management of change in an industry that has been traditionally skeptical of the need or desire to improve systems that aren’t actually broken.
19/01/2010 Day Course	GMP עיקור בסביבת Professional management: Ms. Yehudith Wexler
	Isranalytica 2010 – Related Events
TBA Day Course	Auditing Manufacturers of Starting Materials Lecturer: Ms. Karen Ginsbury
	At the end of this course participants will understand how to pre-audit, how to schedule and conduct effective audits in limited timeframes and how to follow up on implementation of effective corrective and preventive actions to your audit findings.

2009

TBA Day Course	Risk Management of APIs Manufacture Lecturer: Ms. Karen Ginsbury
TBA Day Course	Audits of APIs Manufacturers Lecturer: Ms. Karen Ginsbury
25/11/2009 2 - Day Course	Regulatory Affairs of Medical Devices Lecturer: Ms. Shoshana Friedman
12/11/2009 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.
TBA 2 - Day Course	Registration of Biosimilars in the European Union Lecturer: Dr. Barbara Jentges
21/10/2009 Day Course	ICH Quality Guidelines - Q1 through Q10 Lecturer: Ms. Karen Ginsbury
	The 9 finalized Q" guidlines and the Q10, almost final "Q" guidline – what are they about?
TBA Day Course	Documenting Clinical Trials Lecturer: Dr. Monica Tocchi
	Writing for and about clinical research in human subjects demands special attention to rules. Learn how to write clear and complete documentation of clinical trials. Effective clinical dossiers are approved more quickly, facilitate protocol compliance and enhance trial quality. This ultimately leads to optimal product labeling, allowing successful marketing and maximization of advertising claims.
22/06/2009 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
TBA 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi
08/06/2009 Day Course	Statistical Criteria for Validation of Analytical Methods Lecturer: Dr. Raphy Bar
	Validation of analytical methods is a common regulatory requirement. Yet, it is a process that is carried out at various levels at different laboratories. However, there is no doubt that a statistical treatment of the validation data brings scientific rigorousness to the experiments and renders the validation report more reliable and more easily acceptable to regulatory agencies. This advanced course concentrates directly on the acceptance criteria of the various performance characteristics of analytical methods and on the statistical tests that answer these criteria.
03/06/2009 2 - Day Course	Analytical Chemistry for non-analytical chemists Lecturer: Dr Malcolm Ross, Switzerland
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.
TBA Day Course	Post-Marketing Strategies for Medical Devices – how to keep your device on the market Lecturer: Ms. Shoshana Friedman
26/05/2009 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.
TBA Day Course	Quality Systems for the Manufacturing of Medical Devices – ISO 13485:2003, and 21 CFR 820 Lecturer: Ms. Shoshana Friedman
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.
26/04/2009 Day Course	Protein Analysis by MS Lecturer: Prof. Dani Gibson
TBA Day Course	Product & Process Lifecycle ICH Q8,Q9,Q10,Q11 Lecturer: Ms. Karen Ginsbury
	This one day seminar will take a novel look at product and process development through marketing in the light of the newest guidances. A draft annex to ICH Q8 has just been issued that provides additional clarification regarding its implementation. Inspectors world-wide are undergoing intensive training and discussions about how to perform Quality by Design (QbD) inspections. Will your company be ready to meet the challenge. These three closely integrated guides are global, consensus guides that are being implemented by EMEA, FDA and worldwide. The course will provide an understanding of the need for the guidances, will review the guidances using case studies to explain how they can be integrated into existing quality systems particularly with a view to QA in R&D.
TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
TBA 3 - Day Course	Registering Your Biologics Product with the FDA Lecturers: Dr. Eli Schmell , Dr. Ruthy Wolfson
	This three day course is a Step by Step guide for registration of a biotechnology product with the US FDA. The course covers all aspects of product registration from a theoretical and practical point of view. Course content and presentation are divided between lectures covering the guidelines and examples of actual registration stages and practical, workshop application by the course participants.
11/02/2009 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.
05/02/2009 Day Course	Analytical Methods - Technology Transfer & Verification Lecturer: Dr. Raphy Bar
	Analytical methods once validated, are often transferred and implemented in other laboratories. Thus, methods can be transferred from an R&D lab to a QC lab in the same or different site, or to an external CRO lab.
TBA Day Course	PIC/S Quality Standards for Drugs Lecturer: Dr. Rachel Karpel
22/01/2009 Day Course	Chiral Recognition and Separation Mechanisms Lecturer: Prof. Nelu Grinberg, USA
	The course will focus on specific interactions between the enantiomeric analytes and each specific chiral stationary phase, rather than the techniques used to separate enantiomers. This approach will allow the participants to understand the strategies for development of a separation of enantiomers, along with the conditions to achieve each type of interaction.

2008

17/12/2008 Day Course	GMPs in the Manufacture of Clinical Trials Material Lecturer: Ms. Karen Ginsbury
	In July 2008, FDA released a final guidance along with a final rule exempting pharmaceutical manufacturers from the provisions of 21CFR part 211 – GMPs for Finished Pharmaceuticals if manufacturing material for use solely in phase I studies. The EU on the other hand has passed legislation requiring batch release and certification of any investigational medicinal product by a Qualified Person. This course will review the new FDA guidance comparing and contrasting it with the EU GMP requirements in Annex 13.
11/12/2008 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
TBA 2 - Day Course	Drug Safety Lecturer: Orit Neudorfer, MD
	This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan.
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).
30/10/2008 Day Course	Polymers in design of drug delivery systems Lecturer: Dr. Adel Penhasi
19/02/2008 2 - Day Course	Medical Device Clinical Studies in Europe & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi, Italy
TBA 2 - Day Course	Regulatory and Clinical Considerations in the Development of Combination Products Lecturer: Dr. Barbara S. Fant, Pharm.D., USA
	Development and FDA approval of a combination product is inherently more complex than individual entity products. This course will provide an overview of the regulatory pathway and the development lifecycle for combination products. Characteristics that are common and those that are unique to medical device, drug, and biologic development will be presented. Considerations in clinical trial design, project management, and clinical monitoring of combination product clinical trials will be presented.

2007