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Canada Regional Forum - Regulatory Inspections & Research Challenges

Regulatory Inspections & Research Challenges, covering Health Canada Inspections, including the CRAC perspective as well.

There is a great mix of presenters with experience of Regulatory inspections, Quality Consultants and those working in the industry on hand to provide insight into the challenges you face.  This is a great opportunity to catch up on all the latest regulatory and industry updates as well as pick up some techniques for the toolbox

This event is always a great opportunity for networking, not only with the experts but also with your fellow colleagues in Pharma.

Being held in collaboration with CRAC

CRAC logo image

 

Speakers to include:

Ovidu Jumanca
Canadian Council Animal Care

Kim McDonald
McDonald-Taylor Consulting

John Patterson
QACV Consulting, LLC

Kara Harrison
FDAQRC

Yasser Farooq
DSTL

Sabrina Ramkellawan
Canadian Institute for Medical Advancement

Milind Nadgouda
RiverArk

Mark Rechkemmer
QA Regulatory Inspection Team, GSK

Rassoulou Diallo
Canadian Institute for Laboratory Accreditation

 

Kindly sponsored by

 

RiverArk logo

 

Programme

Please note this is subject to change

 8.30 Registration 
 9.00 Opening meeting 
 9.15 The Importance of Well-Defined Inspection Procedures
 10.00 Animal Welfare Regulatory Framework - a Canadian Perspective
 10.30 Refreshment break 
 11.00 GUI-0100 Guideline to Part C Division 5
 11.45 Staying Ahead of Regulatory Agency Electronic Data Integrity Expectations During Inspections 
 12.30 Lunch 
 13.30 Are You Inspection Ready? 
 14.15 Lightning Talks/Updates
ICH E17 (Multi-regional Clinical Trials)
Medical cannabis, Quality, Research
 15.15  Refreshment break
 15.30 Inspections Readiness for GCP and GPV Inspections 
 16.15 Inspection Preparation, Hosting, Post Inspection Activity - Inspected Perspective 
 17.00 Q&A Session and Closing Thoughts 
 17.30 End of day 

The venue is Fairfield by Marriott Montréal Airport (www.marriott-dorval.com )

700, avenue Michel Jasmin | Dorval (QC) H9P 1C5

 

If anyone requires a room - Please could you book the hotel using the following information for the preferential rate:

 

"Guests who wish to call in to make their room reservation will need to mention the group code (G2518) to have the rate."

The following reservation link can also be used;  Book your group rate for The RQA  

It can be shared with anyone that would need to make a reservation.

We will need a minimum of ten guest rooms for the group rate. this includes free parking and shuttle to/from the airport, breakfast and wifi

 

GROUP ROOM RATES: 24/25/26 September 2019

Hotel confirms the following group rates in Canadian dollars:

 

KING - Standard room with 1 King bed, single - double (occupancy) - $179.00

EXKS - Studio suite with 1 King size bed pull out couch, Single to quad occupancy - $189.00

QNQN - Standard room with 2 Queen beds, (single - quadruple occupancy) - $179.00

EXQS - Studio suite with 2 Queen size beds and pull out couch, Single to quint occupancy - $199.00

Rates are not inclusive of taxes (19%) and a minimum of 10 rooms are required to be eligible for group rates.

Please can you let the everyone know to make a booking asap if needed, as the Hotel will release all unreserved rooms for general sale at the end of August 2019.

 

Free parking is also available for Day delegates

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