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Nov 2009
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Sun, Nov 8, 2009


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Wed, Nov 11, 2009
PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Thu, Nov 12, 2009
PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Mon, Nov 16, 2009
GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Lands End, Mumbai, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Mon, Nov 16, 2009
9:00am
Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels)
To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Wed, Nov 18, 2009
GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Palace, New Delhi, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Wed, Nov 18, 2009
9:00am
Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels)
To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Thu, Nov 19, 2009
European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009
European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009
GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Krishna, Hyderabad, India)
The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Fri, Nov 20, 2009
9:00am
Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels)
To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Wed, Jan 20, 2010
EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 21, 2010
EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Tue, Feb 2, 2010
ANNUAL CONFERENCE ON INTERNATIONAL SPORTS LAW - A Year in Sports Law - Seminar (Institute of Directors, London )
This conference will consider and discuss the key issues in sport and in particular sports law from the last 12 months. Each major sport will be reviewed by a panel of experts and key decision makers from that sport following a short presentation on the key developments from the preceding 12 months. Chairman: Richard Verow Head of Legal, Sky Sports.
Wed, Feb 10, 2010
5th Annual Drug Delivery Systems Conference - Conference (BSG House, London, UK)
Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years. Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning. The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.
Thu, Feb 11, 2010
5th Annual Drug Delivery Systems Conference - Conference (BSG House, London, UK)
Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years. Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning. The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.



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