Biotech China 2014
4th Annual Audits and Inspections for Clinical Trials and Pharmacovigilance
Hotel Bloom
rue Royale 250
Brussels, Belgium
http://www.informa-ls.com/audits
4th Annual Audits and Inspections for Clinical Trials and Pharmacovigilance
Informa Life Sciences
http://www.informa-ls.com/audits
Hotel Bloom
rue Royale 250
Brussels
Belgium

Schedule of Presentations:

Wednesday, November 26, 2008
08:15:00 Coffee and registration
09:00:00 Opening remarks from the Chairperson Brenda Scarth,
09:10:00 Burning questions on GCP and pharmacovigilance inspections answered by AEMPS, Spain Ernesto Vera-Sánchez,
09:50:00 Issues of vital importance on GCP and pharmacovigilance inspections - IGZ’s point-of-view Jeanet Eland-Gerritsen,
10:30:00 Morning networking refreshments
10:50:00 Responses on crucial concerns with GCP and pharmacovigilance inspections by INFARMED Celeste Freire,
11:20:00 Essential answers on key issues concerning GCP and pharmacovigilance inspections by the NIP Kálmán , Várady, Géza Berecz,
12:00:00 PANEL DISCUSSION:What gives rise to a critical finding in inspections? Your opportunity to ask the regulatory authorities Ernesto Vera-Sánchez,, Thierry Roisin,, Kálmán , Várady, Jeanet Eland-Gerritsen,
12:30:00 Networking lunch
13:40:00 Vital information to prevent clinical trial misconduct and fraud penalties Peter Marks,
14:10:00 An extensively experienced guide to MHRA sponsor and site inspections, including a comparison to FDA site inspections in Europe Paul Strickland,
14:40:00 PANEL DISCUSSION: The latest approach to patient-informed consent procedures – what do the inspectors think? Jeanet Eland-Gerritsen,, Kálmán , Várady
15:10:00 Afternoon networking refreshments
15:10:00 Afternoon networking refreshments
15:30:00 Updates on what to expect when regulators conduct GCP and pharmacovigilance inspections: Case study on MHRA (UK), BfArM (Germany), PMDA (Japan), IMB (Ireland), SUKL (Czech Republic), AGEMED (Spanish), EMEA (Europe) Nick Phillips,
16:00:00 Essential knowledge on auditing external providers Angela Cann,
16:30:00 Maximising the value of CRO relationships in developing audits together Elisabetta di Martino,
17:00:00 Closing remarks from the chairperson Brenda Scarth,
17:05:00 End of conference day one
Thursday, November 27, 2008
08:00:00 Announcement
08:15:00 Coffee and registration
09:00:00 Opening remarks from the Chairperson Brenda Scarth,
09:10:00 Effective techniques to fulfil what the pharmacovigilance inspectors are looking for Noha Kassem,,
09:40:00 Approaches on getting the most out of the QPPV role (Qualified Person – Pharmacovigilance) Dominique Delattre,
10:10:00 Morning networking refreshments
10:30:00 Successful strategies for facilitating pharmacovigilance inspections Neil Murray,
11:00:00 QUESTION & ANSWER SESSION – Izabella Bossowska,
11:30:00 Essential guidance from the legal and regulatory requirements to ensure an inspection proof Pharmacovigilance process Thomas Steinbach,
12:00:00 Effective techniques to fulfil what the GCP inspectors are looking for Corinne Pierfitte,
12:30:00 Networking lunch
13:10:00 Essential update on inspector requirements: quality management systems with a risk based approach - how can this be implemented? Peter Schiemann,
13:40:00 Real life experience of an FDA Sponsor Inspection – how to cope with the increasing requirements of the inspection process Peter Odenthal,
13:40:00 Strategies for successful audit procedures: quality management through risk assessment Kristel Vandevoorde,
15:10:00 Afternoon networking refreshments
15:30:00 Winning strategies on the risk based approach to pharmacovigilance audits Allison Jack,
16:00:00 Getting the most out of audits – best practice in pharmacovigilance audits Veerle Noppen,
16:30:00 Overcoming the challenges of clinical trials and audits and inspections in Japan Brenda Scarth,
17:00:00 Closing remarks from the chairperson Brenda Scarth,
17:05:00 End of conference
4th Annual Pharma R&D Asia Congress
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