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IIR PTI
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| Advanced European Regulatory Affairs |
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Tue 09 Feb 2010
- Thu 11 Feb 2010
Regus Trafalgar Square, London, England
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Tue 22 Jun 2010
- Thu 24 Jun 2010
Regus St. James's Park, London, England
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Regulatory adherence is imperative for obtaining and maintaining marketing authorisation. The advanced regulatory training course examines current European legislation and the consequences of the changes in European legislation. It also takes a look at and compares regulatory requirements between Europe and the rest of the world. This advanced course provides a forum that enables delegates to identify common problems and solutions through open discussions with their colleagues, counterparts and the trainer.
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Exploring and assessing current European legislation and identify common problems
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Overcoming the challenges presented by continued changes to European regulatory affairs
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Examining the pros and cons of the globalisation of regulatory affairs
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Determining the role of the Regulatory Affairs Manager
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Successful strategies to ensure compliance with current regulatory affairs
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Avoiding the pitfalls of new European regulations
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Developing and maintaining labelling strategies to conform with the regulatory affairs of your target market
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Managing pharmacovigilance in an ever changing world
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Optimising the effectiveness of your pharmacovigilance system
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Expeditious product lifecycle management
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Who Will Attend?
Anyone working within the field of regulatory affairs at management level
• Regulatory Affairs Manager
• Strategy Management
• Regulatory Affairs Officer
• Quality Manager
• Regulatory Affairs Specialist
• Regional Coordinator
• Regulatory Affairs Associate
• Development Pharmacist
• Pharmacovigiliance Manager
• Regulatory Affairs Attorney
• Regulatory Affairs Executive
• Project Managers
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Course Leader
Dr. Hoss A. Dowlat, Ph.D.
Title: Principal Consultant, Drug Development Consulting Practice
Responsibilities:
- Provides a full regulatory and drug development strategic consulting service to the pharmaceutical industr
- Provides high level consulting in due diligence of new drug candidates or technology platforms, full development programmes, technical content and safety issues, optimising labelling
- Presents extensively at conferences and trains Europe-wide industry and regulatory authority/agency officials in regulatory requirements concerning product information, label claims, EU enlargement, variations and the CTD
- Publishes on a wide scope of international regulatory affairs aspects of medicines, including as a co-author of a 290 page 2002 SCRIP report on pharmacovigilance.
Expertise: Hoss Dowlat, a dual British/Canadian citizen educated in England, joined PAREXEL in 2000.
Hoss focuses on FDA/EMEA regulatory strategy, technical content and safety issues impacting biologics MAA/NDA/BLA regulatory filings, Labelling, and on the writing of pharmaceutical and clinical expert reports and CTD modules 2.
He is a multidisciplinary, science-based regulatory affairs senior manager and a strategic thinker with 27 years of experience in North American and European pharmaceutical industry. Hoss has been involved with multidisciplinary Drug Development and Approval of Drug packages for the EMEA, the EU National Agencies, TPP (Canada) and the FDA in over 14 therapeutic categories. He has conducted pharmaceutical and clinical development in all dosage forms of conventional and biotech drugs, in particular sterile and injectable drugs.
Before joining PAREXEL, Hoss Dowlat developed his pharmaceutical industry experience as follows: his initial eight industry years were in drug discovery in Fisons Rhone-Poulenc UK; then seven years in Regulatory Affairs in the companies Searle and Novopharm in North America; and in addition, seven years as a Regulatory Consultant to American and European multinational and medium-sized pharmaceutical companies while at the CRO Phoenix International Life Sciences based in Montreal, as an independent Regulatory Consultant in PharmaBio Hamburg, and in an established UK medical and regulatory agency, Quantum Medical, in London.
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