Investigator Training Program 2022 opens for registration

21 September 2022

Clinical Trials BC and Pfizer are partnering to bring a clinical trial investigator training course to British Columbia this November 2, 2022. Completion of this course satisfies Good Clinical Practice training requirements and TransCelerate mutual recognition criteria for conducting clinical trials.

The Investigator Training Program (ITP) is a one-day, hybrid workshop (virtual & in-person) designed for clinical trial investigators and other research team members in BC who are interested in improving how they plan, conduct, and report on their clinical trials.

This interactive workshop will include lectures, practical recommendations for enhancing efficiency and efficacy of trial conduct, and discussions with experts in clinical trial operations. The training will be divided into 7 modules covering the entire trial process from the planning stages through trial close-out activities.

Topics

  • Clinical Trials Overview
  • Study Start-Up
  • Informed Consent
  • Conducting a Study
  • Study Oversight
  • Safety in Clinical Trials
  • Regional Regulations Governing Clinical Trials

Target audience

  • Investigators
  • And their delegated clinical research team members (research managers, coordinators, etc.)

* Please note that this training opportunity is available to BC-based researchers.

How to participate

This event is hosted by Clinical Trials BC. Admission to this training workshop is free for investigators and research teams in BC attending in person and virtually. Handouts and training materials will be provided.

In-person participation

There are 30 seats available. Lunch and refreshments will be provided. Proof of vaccination will be checked to attend.

Virtual participation

Attendees can join virtually via Zoom. Once registered, participants will receive an access link and training materials via email before the event date. Participating the entirety of the training is required to receive the training certificate.

Training certificate

Attendees who complete the training will receive a training certificate accredited by TransCelerate.

To receive the Transcelerate GCP certificate, attendees are expected to attend the entire duration of the training.

 


Registration

Please contact Nhan Do – Education & Communications Coordinator if you have any questions or need assistance.

Agenda

Presenters

 

Module Presenter Bio Headshot
Clinical Trials Overview Kathleen Tobin Kathleen Tobin is a Site Relationship Partner at Pfizer Canada Inc. She graduated from the University of Montreal with a Bachelor’s Degree of Sciences in Nursing. She was Head Nurse of a Coronary Care Unit before transferring to clinical research 33 years ago. She has dealt with the whole spectrum of phases, therapeutic areas, and partnerships at the Canadian and international level mostly in the industry but also in the hospital setting for a few years. She has held roles such as SOP Administrator, Trainer, GCP Auditor, Study Manager, Head of a Phase I-II Unit, Oversight Lead as well as Clinical Study Budget & Feasibility Manager. She was an industry coordinator for the Specialized Graduate Diploma interns of the University of Montreal’s Faculty of Pharmacy for 13 years and a Speaker at the Laval University’s Faculty of Pharmacy as part of their Micro-Program on Pharmaceutical Development where she gave a class on GCP for 6 years.

 

Study

Start-Up

Talia Pakos Talia Pakos is a Country Trials Manager at Pfizer Canada Inc. where she is working on several trials predominantly in the Oncology portfolio. Talia graduated from McGill University and holds a degree in Microbiology and Immunology. She has over 30 years of experience in the biotech and pharmaceutical industry, of which 22 years have been with Pfizer. Talia has also had a role as a Medical Effectiveness Business Solutions Lead in Medical Affairs, where she built on her experience in operational effectiveness and the implementation of process and tools. She has previously held the roles of Clinical Operations Manager and Business Unit Liaison, Clinical Development Manager, Project Manager, and Clinical Study Manager. Talia also has clinical experience in project management of phase 1-4 clinical trials across multiple therapeutic areas, management of cross-functional teams and CRO oversight. In her spare time, Talia enjoys spending time with her family, travelling and has a passion for drawing and painting.

 

Informed Consent Claudia De Paola Claudia De Paola is a Site Relationship Partner Director at Pfizer Canada Inc.  She leads a team of Site Relationship Partners who are accountable for start up activities through activation and responsible for building and retaining investigator site relationships. She holds a Bachelor’s degree in Science (Physiology) from McGill University as well as a Master’s degree in Science (Clinical Research Administration) from George Washington University. She has over 20 years experience at Pfizer supporting clinical trial execution.  Prior to her current position, Claudia has held roles in monitoring, site/project management and study oversight, covering all phases of drug development and working in a variety of therapeutic areas but most notably in internal medicine and oncology. She is very passionate about study start up and overall site management. When she is not working at supporting clinical programs at Pfizer, Claudia enjoys staying active with her 2 kids who are both in competitive soccer (paying tribute to her Italian culture) and hockey (as a true Canadian)!

 

Conducting a Study Raymonde Shaw Raymonde Shaw is a Site Relationship Partner at Pfizer Canada Inc. where she is currently working on several trials predominantly in the Oncology portfolio. Ray graduated as a Respiratory Therapist. Ray has over 25 years of experience in the biotech and pharmaceutical industry, of which 7 years have been with Pfizer. She has previously held the roles of Clinical Team Manager, Clinical Operations Lead, Clinical Research Associate and Trainer and has clinical experience in phase 1-4 clinical trials across multiple therapeutic areas. In her spare time, Ray enjoys spending time with her family/friends, travelling, cycling and cooking.

 

Study

Oversight

Ramona Valadka Ramona Valadka is a Site Excellence Partner at Pfizer Canada Inc. She graduated from the University of Toronto with a Bachelor of Science Degree (Neurophysiology). She continued her studies to graduate as a Respiratory Therapist working for 20 rewarding years in hospitals across Canada in various critical care areas such as NICU, ICU, Cardiovascular surgery, and Trauma Centers. Ramona has over 20 years clinical research experience joining Pfizer in 2008. She has experience working in all clinical trial phases across a variety of therapeutic areas such as oncology, hematology, neurology, gastroenterology, inflammation, and immunology, for various demographics from pediatrics to adults. Ramona enjoys all outdoor activities throughout all our glorious Canadian seasons…the colder, the better!

 

Safety in

Clinical Trials

Fahima Chalal Fahima is a Site Relationship Partner within the Pfizer Clinical Operations team and the main Pfizer point of contact for investigative sites. As part of her role, she is accountable for site start-up activities through site activation and ensures sites continue to receive the necessary support throughout the lifecycle of studies. She is currently working on several trials in various therapeutic areas including Oncology, NASH, Lupus, T2DM & Obesity. Prior to joining the Pfizer Clinical team, she held a position as a Safety Data Management Specialist within Pfizer’s Drug Safety Unit. Fahima has extensive experience in Pharmacovigilance including the oversight of Patient Support Programs and Vendors from a Safety standpoint as well as the management of various outsourced Pharmacovigilance activities. She has a strong knowledge of the Canadian Pharmacovigilance Regulations and Good Pharmacovigilance Practices. Fahima also has prior experience in Medical Information. In her free time Fahima loves to bake and often spend hours making tasty treats for her loved ones! She loves to spend time outdoors and also likes to paint when it’s too cold to go outside!

 

Regional Regulations Governing Clinical Trials  

Aline Silahian

 

 

 

 

 

 

Naela El Hoss

Aline Silahian is an Associate Director, Regulatory Affairs at Pfizer Canada, leading the Regulatory Strategy team responsible for Inflammation & Immunology, Rare Disease, and Vaccines. Aline has over 24 years experience in the Pharmaceutical Industry. She joined Pfizer in 2003 as a Manager within the Clinical Trial Application Unit. She later took on the role of Associate Director Regulatory Affairs and, within this role, in addition to her current portfolio, she has led teams responsible for a diverse portfolio including Anti‐infectives/HIV, Men & Women’s Health, Endocrinology, Ophthalmology, Respiratory, and several established brands. Aline began her career in the Pharmaceutical Industry at Abbott Laboratories Canada where she established internal Safety processes & systems and took on roles with increasing responsibility and led a team responsible for Pharmacovigilance/Safety and Regulatory Affairs. Aline holds a bachelor’s degree in pharmacy and a post-graduate degree (diploma in Drug Development-Clinical Research) from University of Montreal. She also worked as a community Pharmacist for several years where she led a number of educational sessions to increase patient awareness on various health topics.

 

Naela EL-Hoss is a manager in Regulatory Affairs at Pfizer Canada, working on the rare disease portfolio. Naela has over 20 years’ experience in the Pharmaceutical Industry. She joined Pfizer in 2004 as an associate within the regulatory affairs department. She later took on the role of Manager Regulatory Affairs and, within this role, she has successfully managed a very diverse portfolio in many different therapeutic areas, including Pain, Pulmonary Arterial Hypertension, Acromegaly, Stem Cell, Duchenne Muscular Dystrophy.  She holds a bachelor’s degree in biochemistry and a graduate diploma in management.

 

 

 

 

 

 

 

Not

Applicable

Mona Maroun Mona Maroun is the Director of Clinical Site Operations, Pfizer Canada. She graduated from McGill University in Montreal and started her experience in the Institutional setting as a Clinical Dietitian. She began her career in Clinical Research in 2001 as a Clinical Research Associate. In 2004, Mona started her career with Pfizer as a Project Manager where she managed clinical trials across multiple therapeutic areas for 6 years. She took an opportunity working with Regional Field Medical Affairs as a project manager in Medical Quality and Compliance, and in 2011 joined the Compliance team within the Legal division as a Senior Manager of Corporate Compliance.  In 2016, Mona returned to Clinical Research as Director Clinical Site Operations leading the Canada country organization within Global Site and Study Operations. In her spare time Mona loves experimenting with new recipes, hosting game night, and skiing with her family in the winter.