GMP UPDATE 2005 - Global Perspectives for; Pharmaceutical, Biopharmaceutical, Medical Device and All (GMP UPDATE 2005)

Venue: Hilton Toronto Airport

Location: Mississauga, Ontario, Canada

Event Date/Time: Jun 06, 2005 End Date/Time: Jun 07, 2005
Report as Spam

Description

The greatest gathering of GMP Experts from across the globe addressing most pressing Issues on GMPs from FDA, Health Canada, European and WHO Perspectives

Strategies to Ensure Regulatory Compliance & Best Practices in GMP

Dear Friends and Colleagues:
It is with great pleasure to invite you to participate in the “GMP UPDATE 2005”, one of the largest GMP Experts gathering on June 6 – 7, 2005, at the Hilton Toronto Airport Hotel located by the Pearson Airport in Toronto, Canada.

This important event promises to deliver the most valuable, multi-leveled conference, offered to pharmaceutical, biopharmaceutical, medical devices and allied industries. It will address compelling issues and the latest changes in GMP regulations and requirements.

This event hosts both national and international eminent expert presenters from; Food and Drug Administration (FDA) CDER, Health Canada BREC and HPFBI, United Kingdom’s MHRA, European Generic Medicine Association EGA, ICH Steering Committee, WHO Expert Committee, and executive industry professionals.

In today’s global market where the globalization of the drug product plays an essential role in companies’ growth and survival, drug manufacturers need to adhere to more demanding standards of GMP imposed by various regulatory agencies. Their products can then meet the approval of major European, North American and other markets. This means companies have to conform to the required specification and ensure that inspections and approvals of their products by all major regulatory authorities are done in a coordinated way and in accordance with current GMP requirements.

This conference will address the implications of what the current key GMP requirements are and how are they changing, or interpreted by various regulatory agencies. The program content is designed and based on the FDA’s revised Good Manufacturing Practices (GMPs) guidelines, WHO new initiatives on GMP, ICH Q7, European Legislation on API manufactures, Health Canada's Pre-Approval inspection process for biologics and many other pressing issues.

The “GMP UPDATE 2005” is the place to be for an unparalleled learning experience and networking opportunities.

This unique event will keep the delegates abreast of the recent developments and give each individual ample opportunities to meet and ask detailed questions from regulatory representatives, who provide you with an understanding of a new direction in Pharmaceutical and biological regulatory activities.

Once again, It will be our pleasure to have you sharing this event with us and we look forward to welcoming you here in Toronto in the very near future.

IPA Executive Committee

GMP Update 2005

Canada's the most Important Strategic pharmaceutical & Biopharmaceutical Event of the Year

Program Highlights

- FDA recent guidance published relating to the GMP program
- FDA future guidance documents and those under revision
- Current guidance and standards for API manufacture
- New EU legislation impacting API manufacture
- EU Guide to GMP – Annex 18
- MHRA Voluntary Inspection Program
- New requirements for Establishment License Application - Health Canada
- Investigational Medicinal Products (IMP) Inspections
- Patent system and regulatory requirements in EU
- GMPs for Biologics - Health Canada
- ICH Regulatory frame work in Q7A
- Implementation of Q7A in Canada for Biologics
- Health Canada's Pre-Approval inspection process for biologics
- cGMP during Biopharmaceutical Development
- WHO New revised GMP guidelines
- GMP for HVAC systems
- GMP Supplementary text on Validation
- GMP: Water for Pharmaceutical Use -
- Sampling of Pharmaceuticals and related materials
- Good Distribution Practices (GDP) for pharmaceutical products
- FDA's system based approach to inspection
- FDA's Update on the Risk-based Site
- Selection model for inspections
- Temperature Control of Drug Products during
- Storage and Transportation - Health Canada
- Post-Market Reporting Compliance - Health Canada
- Standard for the fabrication, control and distribution of anti-microbial agent
- GMP Compliance for Vaccines

REGISTER NOW SPACES ARE LIMITED

DISTINGUISHED SPEAKERS & MODERATORS

Tonino Antonetti
Drug Specialist, HFBI-Health Canada

Merry Bujaki
Manager, EL Unit, HFBI-Health Canada

Dr. Nicholas F. Cappuccino
Vice-President, Sandoz - USA
ICH Steering Committee Member
WHO Expert Committee Advisor

Dr. Jeremy Desai
Senior Vice-President R&D, Apotex Inc. - Canada

Dr. Rajesh K. Gupta
Senior Consultant at the Biologics Consulting Group, USA

Mr. Thomas McLerie
Director of Quality, Genpharm Inc. - Canada

Ms. Grace McNally
Compliance Officer, FDA-CDER

Mr. Greg Perry
Director General of the European Generic Medicines Association (EGA)-EU

Dr. Harold Rode
Unit Head, BREC- Health Canada

Dr. Paula Shadle
President, Shadle Consulting, USA

Johanne St-Denis
Compliance Officer, HFBI-Health Canada

Carolina Ulloa
Drug Specialist, HFBI-Health Canada

Mr. Bryan Wright
Unit Manager, MHRA-UK





The greatest gathering of GMP Experts from across the globe addressing most pressing Issues on GMPs from FDA, Health Canada, European and WHO Perspectives

Strategies to Ensure Regulatory Compliance & Best Practices in GMP



More Details...
Program Highlights
Forum Speakers
Who Should Attend?
Hotel & Seminar Location: Program Agenda
Seminar Registration Fee
Methods of payment
Online Register



Dear Friends and Colleagues:

It is with great pleasure to invite you to participate in the “GMP UPDATE 2005”, one of the largest GMP Experts gathering on June 6 – 7, 2005, at the Hilton Toronto Airport Hotel located by the Pearson Airport in Toronto, Canada.

This important event promises to deliver the most valuable, multi-leveled conference, offered to pharmaceutical, biopharmaceutical, medical devices and allied industries. It will address compelling issues and the latest changes in GMP regulations and requirements.

This event hosts both national and international eminent expert presenters from; Food and Drug Administration (FDA) CDER, Health Canada BREC and HPFBI, United Kingdom’s MHRA, European Generic Medicine Association EGA, ICH Steering Committee, WHO Expert Committee, and executive industry professionals.

In today’s global market where the globalization of the drug product plays an essential role in companies’ growth and survival, drug manufacturers need to adhere to more demanding standards of GMP imposed by various regulatory agencies. Their products can then meet the approval of major European, North American and other markets. This means companies have to conform to the required specification and ensure that inspections and approvals of their products by all major regulatory authorities are done in a coordinated way and in accordance with current GMP requirements.

This conference will address the implications of what the current key GMP requirements are and how are they changing, or interpreted by various regulatory agencies. The program content is designed and based on the FDA’s revised Good Manufacturing Practices (GMPs) guidelines, WHO new initiatives on GMP, ICH Q7, European Legislation on API manufactures, Health Canada's Pre-Approval inspection process for biologics and many other pressing issues.

The “GMP UPDATE 2005” is the place to be for an unparalleled learning experience and networking opportunities.

This unique event will keep the delegates abreast of the recent developments and give each individual ample opportunities to meet and ask detailed questions from regulatory representatives, who provide you with an understanding of a new direction in Pharmaceutical and biological regulatory activities.

Once again, It will be our pleasure to have you sharing this event with us and we look forward to welcoming you here in Toronto in the very near future.

IPA Executive Committee

Back to Top




GMP Update 2005

Canada's the most Important Strategic pharmaceutical & Biopharmaceutical Event of the Year


Program Highlights

FDA recent guidance published relating to the GMP program
FDA future guidance documents and those under revision
Current guidance and standards for API manufacture
New EU legislation impacting API manufacture
EU Guide to GMP – Annex 18
MHRA Voluntary Inspection Program
New requirements for Establishment License Application - Health Canada
Investigational Medicinal Products (IMP) Inspections
Patent system and regulatory requirements in EU
GMPs for Biologics - Health Canada
ICH Regulatory frame work in Q7A
Implementation of Q7A in Canada for Biologics
Health Canada's Pre-Approval inspection process for biologics
cGMP during Biopharmaceutical Development
WHO New revised GMP guidelines
GMP for HVAC systems
GMP Supplementary text on Validation
GMP: Water for Pharmaceutical Use
Sampling of Pharmaceuticals and related materials
Good Distribution Practices (GDP) for pharmaceutical products
FDA's system based approach to inspection
FDA's Update on the Risk-based Site Selection model for inspections
Temperature Control of Drug Products during Storage and Transportation - Health Canada
Post-Market Reporting Compliance - Health Canada
Standard for the fabrication, control and distribution of anti-microbial agent
GMP Compliance for Vaccines

REGISTER NOW SPACES ARE LIMITED

Back to Top






DISTINGUISHED SPEAKERS & MODERATORS


Tonino Antonetti
Drug Specialist, HFBI-Health Canada
Merry Bujaki
Manager, EL Unit, HFBI-Health Canada
Dr. Nicholas F. Cappuccino
Vice-President, Sandoz - USA
ICH Steering Committee Member
WHO Expert Committee Advisor

Dr. Jeremy Desai
Senior Vice-President R&D, Apotex Inc. - Canada
Dr. Rajesh K. Gupta
Senior Consultant at the Biologics Consulting Group, USA
Mr. Thomas McLerie
Director of Quality, Genpharm Inc. - Canada
Ms. Grace McNally
Compliance Officer, FDA-CDER
Mr. Greg Perry
Director General of the European Generic Medicines Association (EGA)-EU
Dr. Harold Rode
Unit Head, BREC- Health Canada

Dr. Paula Shadle
President, Shadle Consulting, USA

Johanne St-Denis
Compliance Officer, HFBI-Health Canada
Carolina Ulloa
Drug Specialist, HFBI-Health Canada
Mr. Bryan Wright
Unit Manager, MHRA-UK
Back to Top

Who Should Attend?

Because of its comprehensive content, this is a Must program for everyone in the pharmaceutical, biopharmaceutical, biologics, Medical Device and allied industries with daily responsibilities in the following areas:

- Quality Control
- Quality Assurance
- Regulatory Affairs
- Product Submission
- API
- Manufacturing
- Validation Services
- Documentation and Technical Writing
- Training
- GMP/GLP Compliance
- Product Submission
- Contract Laboratories
- Consultants
- Contract manufacturing

Venue

5875 Airport Road
Mississauga
Ontario
Canada
MORE INFO ON THIS VENUE

Additional Information

Course Registration Fee For: "GMP UPDATE 2005 GLOBAL PERSPECTIVES ” Registration Fee - $780.00 (CAD) + GST (7%) Goverment Employees & Students - $550.00 (CAD) + GST (7%)