03 Mar 2016

Ontario, Canada - Intertek, the leading provider of quality and safety services to industries worldwide and Health, Environmental and Regulatory Services (HERS), is pleased to announce that we will be giving a presentation on ‘How ICH M7 Regulatory Guidance is used to Support Toxicological Risk Assessment of Impurities in Drugs and Combination Products’, and has been invited to present five published scientific research posters at the Society of Toxicology (SOT) Annual Meeting in New Orleans, LA from March 13-17, 2016.

Intertek experts Ms. Lois Haighton, Director, Food & Nutrition Group and Dr. Gyuri Vas, Research Fellow, Manager Trace Organic Laboratory will present ‘How ICH M7 Regulatory Guidance is used to Support Toxicological Risk Assessment of Impurities in Drugs and Combination Products’ on March 16, 2016 from 13:30 - 14:30 in Room 212. The recent ICH M7 guidance provides a framework for a step-wise approach for analysis of drug products, and the risk assessment of impurities, the scientific principles of which can be extrapolated to other drug-related evaluations. Potential applications and limitations of ICH M7 are discussed from an analytical and toxicological prospective. Intertek will be able to address your questions during this one hour presentation session.

Intertek will also present five scientific posters at SOT. These poster sessions provide attendees with the opportunity to gain first-hand knowledge about the latest research and advances. “Intertek Scientific & Regulatory Consultancy has been an active participant in the SOT Annual Meeting for more than 20 years”, says Ms. Haighton, “and during this time, we have seen useful advancements in scientific research, and improvements in regulatory policies, arising from this opportunity for individuals from government, academia and industry to come together at the SOT Meeting to interact and share ideas about the diverse areas that toxicology impacts. My colleagues and I are honoured that this year’s SOT Scientific Program Committee, who reviews more than 2,500 abstracts and selects only those that are appropriate for this event’s objectives, has invited Intertek to present five of our most recent scientific papers.”

Abstract Number/Poster Board number: 2150/P634
Abstract Title: Applying the "Severe Toxicity" Factor for Non-genotoxic Carcinogenicity When Deriving PDE Values
Presenting Author: Jeffrey Card
Session Title: Risk Assessment 1
Presentation Date and Time: 3/15/2016 9:30:00 AM to 3/15/2016 12:45:00 PM
Presentation Location: CC Exhibit Hall or Great Hall A

Abstract Number/Poster Board number: 2151/P635
Abstract Title: Derivation of a Permitted Daily Exposure Value for Vincristine as a
Carryover Contaminant in Drug Product
Presenting Author: Hana Fikree
Session Title: Risk Assessment 1
Presentation Date and Time: 3/15/2016 9:30:00 AM to 3/15/2016 12:45:00 PM
Presentation Location: CC Exhibit Hall or Great Hall A

Abstract Number/Poster Board number: 2268/P198
Abstract Title: Clinical Safety Evaluation of the Novel Probiotic Bacillus subtilis CU1
Presenting Author: Alexandra Lobach
Session Title: Food Safety/Nutrition 1
Presentation Date and Time: 3/15/2016 1:15:00 PM to 3/15/2016 4:30:00 PM
Presentation Location: CC Exhibit Hall or Great Hall A

Abstract Number/Poster Board number: 2286/P216
Abstract Title: Assessment of Liver Enzyme Changes Among NHANES Respondents and Association with Use of Dietary Supplements
Presenting Author: Shafagh Fallah
Session Title: Food Safety/Nutrition 1
Presentation Date and Time: 3/15/2016 1:15:00 PM to 3/15/2016 4:30:00 PM
Presentation Location: CC Exhibit Hall or Great Hall A

Abstract Number/Poster Board number: 2667/P167
Abstract Title: Assessment of Dietary Exposures to Inorganic Arsenic from Rice and Compliance with California Proposition 65
Presenting Author: Lois Haighton
Session Title: Risk Assessment 2
Presentation Date and Time:  3/16/2016 9:30:00 AM to 3/16/2016 12:45:00 PM
Presentation Location: CC Exhibit Hall or Great Hall A

During SOT, representatives from Intertek’s pharmaceutical team will also be available for consultation at booth #1405. SOT attendees are encouraged to stop by the Intertek booth to discuss their company’s specific requirements. To learn more about our services for a wide range of pharmaceuticals, biopharmaceuticals, food and supplement products and the larger Intertek organization, please visit https://www.intertek.com/pharmaceutical/.

For Market Inquiries:
Lois Haighton, B.Sc., DABT, ERT
Director
Intertek Scientific & Regulatory Consultancy
Telephone: 905-542-2900
Email: lois.haighton@intertek.com

For Media Inquiries:
Tracy Veale
Marketing Manager
Global Health, Environmental & Regulatory Services
Intertek
Direct: 905-286-4182
Email: tracy.veale@intertek.com

About Intertek

Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 38,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com