Bioforum International

Upcoming

2011

TBA Day Course	Technical Files - Assembling, Preparing and Writing for the MDD Lecturer: Dr. Christian Jarling
TBA 3 - Day Course	The Analysis and Characterization of Protein Therapeutic Drugs Lecturer: Mr. David Carr
TBA 2 - Day Course	Preparative High Performance Liquid Chromatography Lecturer: Dr. Henri Colin
	This course is intended for production managers, chemical engineers and chemists in the pharmaceutical industry who want to understand the principles of PHPLC and some of its key features for successful applications at pilot and production levels.
TBA 2 - Day Course	Biocompatibility Evaluation of Medical Device & Biomaterials Lecturer: Dr. Shayne Gad
	The goal of this course is to enable you to develop new medical devices faster, more efficiently and with less expense by giving you a practical working knowledge of biocompatibility and device development.
TBA Day Course	Efficient Management in Quality Operation Lecturer: Mr. Rafi Maslaton
TBA 2 - Day Course	Quantitative Analysis by LC–MS Lecturer: Dr. Wilfried Niessen
	One of the most important applications of LC–MS is its use in routine quantitative analysis, in preclinical and clinical studies to sustain drug development, and in food safety and environmental analysis. This two-day course pays specific attention to aspects related to quantitative analysis by LC–MS for pharmaceutical applications as well as quantitative (multi)residue analysis by LC–MS for environmental and food-safety applications.
TBA 2 - Day Course	Sterilization by Ethylene Oxide Lecturer: Mr. Daniel Floyd
TBA Day Course	Troubleshooting in Sterilization & Microbiological Testing of MD Lecturers: Mr. Daniel Floyd, Mr. Martell Winters
TBA 3 - Day Course	Non-Clinical Drug Safety Evaluation and Drug Development Lecturer: Dr. Shayne Gad
	This course provides a comprehensive explanation of the non-clinical development of drugs, biologics and combination products, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.
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

12/09/2010 2 - Day Course	Retrieving Compound Identity Using LC–MS–MS Lecturer: Dr. Wilfried Niessen
	This two-day course provides knowledge for structure elucidation of small molecules (drugs, pesticides, natural products, etc.) by combined liquid chromatography–tandem mass spectrometry (LC–MS–MS). We study the fragmentation of positively and negatively charged even-electron ions in MS–MS, and discuss identification strategies, both from data-acquisition and from data-processing point of view. Next to lectures and time for questions and discussion, the Course provides exercises in order to practice spectral interpretation.
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.
08/11/2010 Day Course	A GMP Inspector’s Perspective on Compliance Lecturer: Mr. Michael Anisfeld, USA
	Effective Quality Risk Management and Corrective + Preventive Action (CAPA) Systems. Minimize Failure, Maximize Profits and Effectively Meet the Latest GMP Compliance Requirements from Inspection Agencies World-wide. Total Compliance to EU GMPs Annex 20 – “Quality Risk Management”
16/11/2010 3 - Day Course	Stabilization of Proteins and Peptides along the Formulation Process Lecturer: Dr. Mark Cornell Manning
22/11/2010 2 - Day Course	MedDRA® : A Comprehensive Training Course Lecturer: Dr Elliot Brown
24/11/2010 Day Course	Tablet Pro Lecturer: Mr. Michael Tousey, USA
	Tablet Pro (Professional) is a one day comprehensive course covering tablet press operations. The participant will gain a complete understanding of the importance of tablet press set-up, machine function, operation, and cleaning.
30/11/2010 2 - Day Course	Rapid Microbiological Methods - RMM Lecturer: Dr. Michael Miller
TBA 2 - Day Course	Risk Management Throughout a Drug Lifecycle Lecturer: Dr Stanley Garbus
	The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
07/12/2010 Day Course	Good Clinical Practice 2010 - Clinical Trials for Medical Device Lecturer: Dr. Monica Tocchi
08/12/2010 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
14/12/2010 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
16/12/2010 Day Course	Fundamentals to Design Strategic Immunogenicity Programs Lecturer: Dr. Ana Menendez, USA
19/12/2010 2 - Day Course	Dissolution Testing Lecturer: Dr Malcolm Ross
	The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
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.
27/12/2010 2 - Day Course	Optimizing the Drug Development Process using PK/PD Modeling Lecturer: Dr. Serge Guzy, USA

Past Activities

2010

21/07/2010 2 - Day Course	European Drug Regulatory Affairs: Strategy and Practice with European Regulatory Procedures Lecturer: Dr. David Jacobs, USA
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
TBA Day Course	Clinical Leadership and Governance for Trial Sponsors Lecturer: Dr. Monica Tocchi
24/03/2010 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr Malcolm Ross
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.
21/03/2010 2 - Day Course	Formulation for Chemists Lecturer: Dr Malcolm Ross
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
21/01/2010 Day Course	CITAC Workshop Lecturers: Dr.I.Kuselman, Dr. W.Koch, Prof.H.Emons, Prof.I.Leito, Prof. P.De Bievre, Dr. J.Messman
	The course will cover metrological principles and practice in analytical laboratories important for quality assurance of analytical results, required by GLP & GMP standards, ISO/IEC 17025 standard, spread for competence of testing laboratories, other international documents and regulations. Use of reference materials as measurement standards, calculation of measurement uncertainty of analytical results, traceability of a routine result to national and international measurement standards and System International of Units (SI), interlaboratory comparisons and proficiency testing are the topics of the course.
19/01/2010 Day Course	GMP עיקור בסביבת Professional management: Ms. Yehudith Wexler
	Isranalytica 2010 – Related Events
17/01/2010 Day Course	Gel Permeation Chromatrography (GPC) Systems in Pharmaceutical Applications Lecturer: Dr. Mark Pothecary, UK

2009

15/12/2009 Day Course	The New Euro Directive for Medical Devices Lecturer: Dr. Christian Jarling
	This seminar gives instructions how to assemble a Technical File in compliance with the European Directives on Medical Devices. This file shall not only comply with the regulatory requirements, but also give an understanding, what a reviewer / auditor expects from a Technical File.
TBA 2 - Day Course	Powder Technology - The Missing Link in Solid Dosage Formulation Lecturer: Dr. Malcolm Ross, Switzerland
	The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.
09/12/2009 2 - Day Course	Technology Transfer Lecturer: Dr Malcolm Ross, Switzerland
02/12/2009 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter
	This course is intended for scientists responsible for the development of film-coated oral solid dosage forms, and scientist, engineers, operators and supervisors responsible for providing technical support with respect to film-coated products.
TBA 2 - Day Course	Registration of Biosimilars in the European Union Lecturer: Dr. Barbara Jentges
TBA 2 - Day Course	Identification of Drug Metabolites using LC–MS–MS Technologies Lecturer: Dr. Wilfried Niessen, The Netherlands
TBA 2 - Day Course	Identification of Endogenous Compounds and Natural Products using LC–MS–MS Technologies Lecturer: Dr. Wilfried Niessen, The Netherlands
TBA Day Course	How to Prepare for a CMDCAS Audit Lecturer: Dr. Christian Jarling
	This seminar is dedicated to manufacturers, who already have a quality management system according to ISO 13485, but who want to integrate the additional regulatory aspects required for Canada. Based on practical examples problem areas and possible solutions will be discussed.
15/07/2009 Day Course	How Current Are You? Review of New Industry and Regulatory Expectations For Biopharmaceutical Products Lecturer: Dr. Ana Menendez, USA
	2008 was a banner year for generating important industry white papers and regulatory guidelines for biopharmaceutical products. This meeting specifically addresses updates that should be implemented in post-2009 development and validation programs both in the GMP and the GLP arena.
13/07/2009 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
05/07/2009 2 - Day Course	Preparing Protocols & Final Reports for Clinical Trial Lecturer: Dr. Shayne Gad
TBA Day Course	Omics Technologies - Theory, Fundamentals, Methods and Applications of – Proteomics, Peptidomics, Glycomics, Metabolomics and Other Omics Lecturer: Prof. Ira Krull, USA
	This course will provide a description and summary of various omics approaches in practice today in the pharmaceutical, chemical, biological, biotechnological, and life sciences areas. These scientific fields of study include ones such as: proteomics, peptidomics, metabolomics, glycomics and other omics for both small and large molecules and their interactions.
TBA 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi
17/06/2009 Day Course	Modern Thin Layer Chromatography Lecturer: Mr. Daniel Handloser, Switzerland
	The course is designed to give a theoretical overview and a practical introduction to the possibilities of modern HPTLC.
TBA 2 - Day Course	Proteins & Related Materials Lecturer: Prof. Ira Krull
	The course will provide a description and summary of the current approaches possible for the characterization of recombinant (synthetic) and natural proteins, peptides and antibodies.
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	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.
31/05/2009 2 - Day Course	Dissolution Testing Lecturer: Dr. Malcolm Ross, Switzerland
	The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
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.
18/05/2009 2 - Day Course	Patient Recruitment Strategy: A Comprehensive Workshop for Investigative Sites and Sponsors Lecturer: Mr. John Needham (USA)
	The course focuses on the skills of the people who are responsible for recruitment success including their personal development (Me), their relationship with their immediate supervisor or client (We) and the role of their efforts in the overall study and the public’s health (Us).
12/05/2009 Day Course	Validation of Analytical Methods for Proteins Lecturer: Prof. Ira Krull, USA
	The course will provide a description and summary of how to develop, optimize, and validate analytical methods for small and large biomolecules. The course will pursue commonly found protein variants and posttranslational modifications in biopharmaceutical products, and how these are commonly assayed for today. Current FDA requirements for protein biopharmaceutical products will also be explored and intensively discussed.
04/05/2009 2 - Day Course	Capsule Technology & Encapsulation of Commercial & Clinical Supplies Lecturer: Mr. Donald K. Lightfoot, USA
	A comprehensive capsule technology presentation covering the manufacturing of empty and filled two piece capsules, fundamentals of encapsulation, blinding of clinical supplies utilizing over-encapsulation and an extensive review of the encapsulation machinery and equipment.
TBA 2 - Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters, USA
TBA 2 - Day Course	Ethylene Oxide Sterilization Lecturer: Mr. Daniel Floyd, USA
	Join us for this two day workshop offering an opportunity to further your understanding of microbiological basics, sterilization basics, ethylene oxide sterilization methods, and discussions on the appropriate way to develop, validate, and optimize your sterilization cycle.
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.
TBA 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr. Malcolm Ross, Switzerland
	Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
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 2 - Day Course	Pharmaceutical Packaging Technology Lecturer: Mr. David Williams, UK
	This intensive course will provide delegates with the knowledge of how packs, for packaging of ethical, OTC and veterinary medicines, are developed, manufactured, filled, transported, stored and used. Packaging is a fundamental part of every marketed product and frequently is fundamental in the success of the product.
16/12/2008 Day Course	Closure manufacture, use & testing Lecturer: Mr. David Williams, UK
	This one-day workshop will provide delegates with the knowledge of how packs are closed to maximise protection of ethical and OTC medicines. A successfully closed pack is a fundamental part of every marketed product and is vital to ensure the success of the product.
TBA Day Course	Theory, Fundamentals, Methods and Applications of Omics Technologies – Proteomics, Peptidomics, Glycomics, Metabolomics and Other Omics Lecturer: Prof. Ira Krull
	This course will provide a description and summary of various omics approaches in practice today in the pharmaceutical, chemical, biological, biotechnological, and life sciences areas. These scientific fields of study include ones such as: proteomics, peptidomics, metabolomics, glycomics and other omics for both small and large molecules and their interactions.
TBA 2 - Day Course	Proteins & Related Materials Lecturer: Prof. Ira Krull
	The course will provide a description and summary of the current approaches possible for the characterization of recombinant (synthetic) and natural proteins, peptides and antibodies.
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).
07/09/2008 2 - Day Course	Pharmaceutical Product Risk Lecturer: Dr Stanley Garbus (USA)
	The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
03/09/2008 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus - USA
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
TBA Day Course	Efficiency in Quality Operation & Managing Batch Records Lecturer: Mr. Rafi Maslaton - USA
	In today's business environment, a quality organization that focuses strictly on compliance while ignoring inefficiency will not succeed. This course discusses efficiency management throughout the quality operations with the main focus on batch record release. While for many years QA was predominantly a compliance organization, and it existence was associated with the cost of doing business, this course will outline how we can manage both compliance and efficiency.
07/07/2008 2 - Day Course	Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland
04/06/2008 2 - Day Course	Powder Technology - The Missing Link Lecturer: Dr. Malcolm Ross, Switzerland
	The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.
02/06/2008 3 - Day Course	The Analysis and Characterization of Protein Therapeutic Drugs Lecturer: Mr. David Carr, USA
	This is a focused course of instruction on the instrumental analysis and characterization of polypeptides. The course emphasizes three important instrumental analytical technologies as they relate to the analysis and characterization of protein therapeutics
12/05/2008 3 - Day Course	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA) Lecturer: Mr. Steve Schwartz
	Roles and Responsibilities for Auditors and Managers
07/04/2008 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr. Malcolm Ross, Switzerland
	Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
TBA 2 - Day Course	Analyzing Biological Assays Lecturer: Dr. John Dunn (USA)
	The course covers nonlinear curve fitting, parallelism and other computations as they relate to bioassay optimization and analysis, and a comprehensive method for evaluating and troubleshooting failed reagents and incubation conditions.
26/02/2008 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter
	This course is intended for scientists responsible for the development of film-coated oral solid dosage forms, and scientist, engineers, operators and supervisors responsible for providing technical support with respect to film-coated products.
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.

2006

22/05/2006 Day Course	Protein structure: a Basis for Developing Protein Therapeutic Drugs Lecturer: Mr. David C. Carr, USA
22/05/2006 Day Course	The role of Proteomics in the research of Diseases & in Drug Discovery Lecturer: Mr. David C. Carr, USA
26/03/2006 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter, Dr. Gadi Ben Meir
19/01/2006 Day Course	Modern HPLC Theory and Practice Lecturer: Prof. Yuri Kazakevich
15/01/2006 2 - Day Course	HPLC Method Development Lecturer: Prof. Yuri Kazakevich