Speakers: Dana Nohynek (CIHR Canadian HIV Trials Network); Will Ruddock (ITR Laboratories); Darrell Panich (Ceros Management and Advisory)
Organizers:
Date: 2019-11-07
Time: 11:00-16:00 Pacific Time
Registration fee: (CDN): Regular: $89
Location: The Floral Hall at VanDusen Gardens, Oak St. at 37th Ave,
Major Sponsor: (1)ITR Laboratories, Inc.
Vendor show vendors registered to date: (3)Altasciences; Catalent Pharma Solutions; SOLVO Biotechnology
Registration: http://www.PBSS.org
Registration deadline:2019-11-05  (it will close sooner if the seating cap is reached)

About the Topic

CDN$109 registration at the door.

Hardcopy of workshop presentations, lunch and refreshments included.

Topics:

• Pre-IND Meeting - Dana Nohynek, MSc, RAC, Director of Regulatory Affairs and Quality Assurance, CIHR Canadian HIV Trials Network.
• Toxicology/ Drug Safety – Will Ruddock, Vice President of Toxicology Operations, ITR Laboratories Canada, Inc.
• Planning for FIH - Darrell Panich M.Sc., PMP, CPM, President, Ceros Management and Advisory Ltd. 

About the Workshop and Who should attend:

• Knowing the objectives, expectations, and processes of assembling and filing an IND or CTA is the key to not only a successful filing but also a promising clinical development path forward. Often, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed, and this can lead to significant delays in clinical development.
• Our speakers are highly experienced with regulatory filings and will discuss systematically the product development strategy for small molecule and biologics filings and the nuts, bolts, and best practices for putting together a high-quality submission package, as well as how to interact with various regulatory agencies.
• The Workshop is separated into two parts both of which are aimed at those working in academic and industry, who are wishing to learn about different aspects of preclinical requirements in drug development, or those who wish to upgrade or broaden their current skills in preclinical and clinical research and development, regulatory affairs, and drug safety in general.