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14/11/2013
1 - Day Course
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Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
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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 |
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13/03/2013
1 - Day Course
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Change Management According to the Q10 Guidelines
Lecturer: Ms. Karen Ginsbury
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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. |
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20/11/2012
1 - Day Course
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Batch Release
Lecturer: Dr. Rachel Karpel
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TBA
2 - Day Course
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Marketing Authorization of Biologicals in the EU
Lecturer: Dr. Barbara Jentges
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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. |
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07/11/2012
1 - Day Course
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The FDA 505 (b) (2) Drug Approval Process
Lecturer: Ken Phelps, President and CEO, Camargo Pharmaceutical Services, USA
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Reduce cost and timelines by using Strategy, Commercial and Regulatory aspects |
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22/07/2012
2 - Day Course
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Analytical Data at the Service of the Regulatory, Formulation and QA Staff
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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09/02/2012
1 - Day Course
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Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
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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 |
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TBA
1 - Day Course
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Documenting Clinical Studies
Lecturer: Dr. Monica Tocchi, Italy
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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. |
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TBA
1 - Day Course
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Medical Device Clinical Studies & Clinical Evaluation for CE Marking in 2010
Lecturer: Dr. Monica Tocchi
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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. |
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14/11/2011
1 - Day Course
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System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
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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. |
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21/09/2011
1 - Day Course
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Batch Release
Lecturer: Dr. Rachel Karpel
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01/06/2011
2 - Day Course
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Marketing Authorization of Biologicals in the EU
Lecturer: Dr. Barbara Jentges
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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. |
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13/04/2011
1 - Day Course
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The European Variations Rules & the Science Behind
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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22/12/2010
2 - Day Course
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Analytical Data at the Service of the QA,
Regulatory & Formulation Staff
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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20/10/2010
1 - Day Course
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GMPs for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
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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. |
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14/09/2010
1 - Day Course
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Color Testing
Lecturer: Dr. Yehuda Shekel
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26/05/2010
1 - Day Course
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System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
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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. |
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22/03/2010
2 - Day Course
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Medical Device Clinical Studies & Clinical Evaluation for CE Marking in 2010
Lecturer: Dr. Monica Tocchi
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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. |
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09/03/2010
6 - Day Course
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RA Managers in the Biomed Industry
Professional management: Ms. Yehudith Wexler
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The biomedical industries - pharmaceuticals, biotechnology, medical devices - have to meet the requirements of the health authorities in order to distribute and market their products. |
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TBA
2 - Day Course
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Drug Safety
Lecturer: Ms. Orit Neudorfer
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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. |
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21/02/2010
Meeting
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Medical Device Companies
Lecturer: Mr. Clay Anselmo
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This course will give an overview on worldwide regulatory frameworks, discussing how to develop Regulatory and QMS strategies to meet the business needs. |
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08/02/2010
1 - Day Course
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Change Management According to the Q10 Guidelines
Lecturer: Ms. Karen Ginsbury
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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. |
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19/01/2010
1 - Day Course
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GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
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Isranalytica 2010 – Related Events |
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TBA
1 - Day Course
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Auditing Manufacturers of Starting Materials
Lecturer: Ms. Karen Ginsbury
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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. |
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12/11/2009
1 - Day Course
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Liposome Applications
Professional management: Dr. Doron Friedman
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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. |
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03/06/2009
2 - Day Course
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Analytical Chemistry for non-analytical chemists
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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26/05/2009
1 - Day Course
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Quality Product Review
Lecturer: Ms. Karen Ginsbury
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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.
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25/05/2009
2 - Day Course
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Managing Extractables and Leachables in Pharmaceutical Products
Lecturer: Ph.D. Edward J. Smith
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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. |
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TBA
1 - Day Course
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Product & Process Lifecycle ICH Q8,Q9,Q10,Q11
Lecturer: Ms. Karen Ginsbury
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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.
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TBA
3 - Day Course
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Registering Your Biologics Product with the FDA
Lecturers: Dr. Eli Schmell , Dr. Ruthy Wolfson
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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. |
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11/02/2009
1 - Day Course
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Risk Management Strategy Planning
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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22/01/2009
1 - Day Course
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Chiral Recognition and Separation Mechanisms
Lecturer: Prof. Nelu Grinberg, USA
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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. |
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17/12/2008
1 - Day Course
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GMPs in the Manufacture of Clinical Trials Material
Lecturer: Ms. Karen Ginsbury
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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. |
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TBA
2 - Day Course
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Drug Safety
Lecturer: Orit Neudorfer, MD
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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. |
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04/11/2008
2 - Day Course
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CMC Submissions in the CTD Format
Lecturer: Carolyn H. Kruse, USA
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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). |
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TBA
2 - Day Course
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Regulatory and Clinical Considerations in the Development of Combination Products
Lecturer: Dr. Barbara S. Fant, Pharm.D., USA
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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.
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