プロフィール詳細

プロジェクトを作成

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Dr. Lawrence S.に依頼

Spain

Freelance Regulatory Toxicologist (chemical and pharmaceutical)

プロフィール概要

I have over 30 years professional experience in regulatory toxicology in the chemical and pharmaceutical Industries and in a Regulatory Agency (Health Canada). I am a Eurotox Registered Toxicologist (ERT) and a member of the Society of Toxicology, and Beltox. I obtained a PhD in toxicology from the University of Saskatchewan (Canada) and MSc and BSc (Hons) in Biology from Carleton University (Canada). The major aspects of my freelance activities include: Serve as the principal scientific contact for contracted toxicity studies, liaise with Study Directors and Scientific staff at testing laboratories, review study protocols, monitor study progress, and assess the regulatory significance of results, including reproductive and developmental (OECD 414, 421, 443), repeat dose toxicity (OECD 408, 422) and genotoxicity studies; Maintain a thorough understanding of the toxicology requirements under the EU REACH regulations and ensure they are addressed proactively; Prepare/collate toxicological data and correspondence for regulatory submission; Conduct literature searches and critically evaluate toxicological data for products or raw materials of interest to clients; Provide expert advice in toxicology, hazard classification, risk assessment and product safety; Liaise with toxicologists, chemists, product stewards and industrial hygienists in chemical companies, regulatory agencies, industry associations, or international organisations with responsibility in toxicology, hazard communication or product stewardship; and Represent clients at meetings with Regulatory Agencies or at consortia/client meetings Prior to becoming a freelance toxicology consultant, I was Director of Nonclinical Toxicology & Pharmacology at GSK Vaccines, where I was responsible for the preparation and review of the non-clinical toxicology sections of regulatory submissions, interactions with regulatory agencies worldwide, planning and review of GLP toxicity studies, and participation in internal safety monitoring boards and project teams. I was also involved in leading and participating in technical projects at EU and US industry associations. Before joining GSK I worked for GE Advanced Materials and Huntsman Europe in senior regulatory toxicology and product safety roles that provided me with experience in chemical health hazard and risk assessment, industry association activities related to toxicology and product safety, occupational toxicology, hazard communication and hazard classification. Prior to moving to Belgium in 2000, I worked for Health Canada as a toxicologist involved in chemical, pesticide and hazardous waste management programmes. I have been an active member of the WEEL (OARS/TERA) occupational exposure committee since 1994.

専門分野

• ☆ Chemistry
• ☆ Pharmaceutical Sciences
• ☆ Vaccine Development

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Gray Literature Search, Systematic Literature Review, Secondary Data Collection

職務経験

Senior Toxicologist (freelance)

Freelance

1月 2018 - 現在

Senior Toxcologist

Penman Consulting

9月 2015 - 12月 2017

Director, Nonclinical Toxicology & Pharmacology, Global Regulatory Affairs

GSK Vaccines

4月 2006 - 8月 2015

Global Toxicology & Regulatory Specialist

GE Advanced Materials

9月 2004 - 3月 2006

Senior Toxicologist/Team Leader, Hazard Assessment

Huntsman Europe

4月 2000 - 8月 2004

Senior Toxicologist and Head, WHMIS Evaluation Section

Health Canada, Product Safety Bureau, WMIS Division

1月 1990 - 3月 2000

学歴

PhD

University of Saskatchewan

9月 1984 - 10月 1987

M.Sc.

Carleton University

9月 1978 - 9月 1980

B.Sc. Hons

Carleton University

9月 1974 - 6月 1978

認定資格

• European Registered Toxicologist (ERT)

  Eurotox / Beltox

  https://beltox.be/belgian-register-of-european-toxicologists/

  9月 2016 - 9月 2021

出版物

JOURNAL ARTICLE

Evaluation of the systemic toxicity and mutagenicity of OLIGOPIN®, procyanidolic oligomers (OPC) extracted from French Maritime Pine Bark extract. @article{PMID:29725583, title = {Evaluation of the systemic toxicity and mutagenicity of OLIGOPIN®, procyanidolic oligomers (OPC) extracted from French Maritime Pine Bark extract.}, author = {Segal L and Penman MG and Piriou Y}, doi = {10.1016/j.toxrep.2018.03.013}, journal = {Toxicology reports}, year = {2018} } . Toxicology reports.

Delannois F, Planty C, Giordano G, Destexhe E, Stanislaus D, Da Silva FT, Stegmann JU, Thacker K, Reynaud L, Garçon N, et al.(2017). Signal management in pharmacovigilance and human risk assessment of CpG 7909, integrating embryo-fetal and post-natal developmental toxicity studies in rats and rabbits . Reproductive toxicology (Elmsford, N.Y.).

Segal L, Thacker K, Fochesato M, Giordano G, Garçon N, Destexhe E(2017). Intramuscularly administered herpes zoster subunit vaccine has no effects on fertility, pre- and post-natal development in Sprague-Dawley rats . Reproductive toxicology (Elmsford, N.Y.).

Giordano G, Segal L, Prinsen M, Wijnands MV, Garçon N, Destexhe E(2016). Non-clinical safety assessment of single and repeated administration of gE/AS01 zoster vaccine in rabbits . Journal of applied toxicology : JAT.

Gérard C, Baudson N, Ory T, Segal L, Louahed J(2015). A Comprehensive Preclinical Model Evaluating the Recombinant PRAME Antigen Combined With the AS15 Immunostimulant to Fight Against PRAME-expressing Tumors . Journal of immunotherapy (Hagerstown, Md. : 1997).

Segal L, Roger V, Williams C, Destexhe E, Garçon N(2015). Effects of Adjuvant Systems on the cardiovascular and respiratory functions in telemetered conscious dogs and anaesthetised rats . Regulatory toxicology and pharmacology : RTP.

Garçon N, Silvano J, Kuper CF, Baudson N, Gérard C, Forster R, Segal L(2015). Non-clinical safety evaluation of repeated intramuscular administration of the AS15 immunostimulant combined with various antigens in rabbits and cynomolgus monkeys . Journal of applied toxicology : JAT.

Segal L, Morelle D, Kaaber K, Destexhe E, Garçon N(2015). Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats . Journal of applied toxicology : JAT.

Segal L, Wouters S, Morelle D, Gautier G, Le Gal J, Martin T, Kuper F, Destexhe E, Didierlaurent AM, Garçon N(2015). Non-clinical safety and biodistribution of AS03-adjuvanted inactivated pandemic influenza vaccines . Journal of applied toxicology : JAT.

Destexhe E, Stannard D, Wilby OK, Grosdidier E, Baudson N, Forster R, Gérard CM, Garçon N, Segal L(2014). Nonclinical reproductive and developmental safety evaluation of the MAGE-A3 Cancer Immunotherapeutic, a therapeutic vaccine for cancer treatment . Reproductive toxicology (Elmsford, N.Y.).

Segal L, Morelle D, Blee M, Moore E, Damsten M, Liu KC, Destexhe E, Garçon N(2014). Local tolerance and systemic toxicity of single and repeated intramuscular administrations of two different formulations of the RTS,S malaria candidate vaccine in rabbits . Regulatory toxicology and pharmacology : RTP.

Destexhe E, Grosdidier E, Baudson N, Forster R, Gerard C, Garçon N, Segal L(2014). Non-clinical safety evaluation of single and repeated intramuscular administrations of MAGE-A3 Cancer Immunotherapeutic in rabbits and cynomolgus monkeys . Journal of applied toxicology : JAT.

Destexhe E, Prinsen MK, van Schöll I, Kuper CF, Garçon N, Veenstra S, Segal L(2013). Evaluation of C-reactive protein as an inflammatory biomarker in rabbits for vaccine nonclinical safety studies . Journal of pharmacological and toxicological methods.

Lorin C, Segal L, Mols J, Morelle D, Bourguignon P, Rovira O, Mettens P, Silvano J, Dumey N, Le Goff F, et al.(2012). Toxicology, biodistribution and shedding profile of a recombinant measles vaccine vector expressing HIV-1 antigens, in cynomolgus macaques . Naunyn-Schmiedeberg's archives of pharmacology.

Garçon N, Segal L, Tavares F, Van Mechelen M(2011). The safety evaluation of adjuvants during vaccine development: the AS04 experience . Vaccine.

Evaluation of the intramuscular administration of Cervarix™ vaccine on fertility, pre- and post-natal development in rats. @article{PMID:20851759, title = {Evaluation of the intramuscular administration of Cervarix™ vaccine on fertility, pre- and post-natal development in rats.}, author = {Segal L and Wilby OK and Willoughby CR and Veenstra S and Deschamps M}, doi = {10.1016/j.reprotox.2010.09.001}, journal = {Reproductive toxicology (Elmsford, N.Y.)}, month = {01}, year = {2011} } . Reproductive toxicology (Elmsford, N.Y.).

Cote R, Davis H, Dimock C, Korpan M, Loewen K, Segal LM(1998). The evaluation and hazard classification of toxicological information for workplace hazardous materials information system material safety data sheets . Regulatory toxicology and pharmacology : RTP.

Lipnick RL, Cotruvo JA, Hill RN, Bruce RD, Stitzel KA, Walker AP, Chu I, Goddard M, Segal L, Springer JA(1995). Comparison of the up-and-down, conventional LD50, and fixed-dose acute toxicity procedures . Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

Segal L, Riedel D, Ritter L(1990). Evaluation of normal human epidermal keratinocyte cultures as a test system for the assessment of the dermal irritancy of pesticides . Toxicology in Vitro.

Segal LM, Fedoroff S(1989). Cholinesterase inhibition by organophosphorus and carbamate pesticides in aggregate cultures of neural cells from the foetal rat brain: The effects of metabolic activation and pesticide mixtures . Toxicology in Vitro.

Segal LM, Fedoroff S(1989). The acute and subchronic effects of organophosphorus and carbamate pesticides on cholinesterase activity in aggregate cultures of neural cells from the foetal rat brain . Toxicology in Vitro.