Pills

Advanced Regulatory Affairs

January 24-26, 2017 | Toronto, Canada


Course Description:

IPA invites you to attend the 3 days comprehensive & Interactive course with discussion on Advanced Regulatory Affairs, to be held on January 24-26, 2017 in Toronto.


Regulatory Affairs is crucial to the successful development, approval, and marketing of pharmaceutical products. The first day and a half will address the Drug Development, Regulatory Agency Contact Points, NDA submissions, NDA Supplements and Electronic submissions (eCTD).


The second half of the course will address the expectations of a regulatory leader and how to develop and implement those skills. Essential regulatory strategies and approval pathways will be discussed, including the requirements and pros and cons of each. Case studies will be reviewed. Creating a risk assessment and associated mitigations will be discussed and applied in a practicum.



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Peggy J. Berry, MBA, RAC

President & CEO

Synergy Consulting LLC


Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Course outline
Day 1 - Tuesday January 24, 2017 and Morning of Wednesday January 25, 2017
  • Drug Development Overview
  • Regulatory Agency Contact Points
  • NDA submissions
    • New chemical entity
    • 505(b)(2)
    • Amendments
  • NDA Supplements
    • Efficacy
    • Quality
    • Labeling
    • Other
  • Electronic submissions (eCTD)
Day 1 Evening Wine & Cheese Sponsored by
Pills
Afternoon of Wednesday January 25, 2017 and Day 3 - Thursday January 26, 2017
  • Discussion of the regulatory role on the product development team
  • Discussion of the levels within regulatory affairs and the expectations of each role
  • Discussion of the leadership qualities expected from regulatory affairs personal
  • How to achieve effective leadership
    • Developing leadership skills
    • Effective communication across the organization
    • Influencing for success
  • Determining your leadership style for success
  • Overview of regulatory pathways in the US and EU
  • Considerations in developing an effective regulatory strategy
    • Options for development of various products
    • Product and data requirements for each option
    • Determining the pros and cons of each approach and how it fits into the company strategy
    • Integrating the regulatory strategy into submissions and agency communications
  • Risk assessment and mitigation strategies
    • How to identify potential risks to the submission and approval of regulatory applications
    • Preparing a rapid response team for regulatory communications
    • Brainstorming and assessing risk mitigation strategies to be poised for rapid action and success
Who will benefit:

This 3 days course is directed towards indiviuals in the Pharmaceutical, Biopharmacuetical, and allied industries with daily responsibilities in the following areas:
  • Regulatory Affairs
  • Quality Assurance
  • Drug Development
  • Product Registration
  • Product Development
  • Clinical Research
  • Compliance
  • Documentation and Technical Writing
  • Submissions
  • Project Management
  • Electronic Submissions
  • Training
Register Early & Save!
Registration Options: Please note this course can be taken in one and a half days or three full days. By taking the 3 full days you will SAVE over $288.
3 days Registration Fee Early Bird:
Till Dec. 08, 2016
Regular Price:
Dec. 09, 2016 to Jan. 24, 2017
Enrol for all 3 days and Save up to $288! $1088 +HST CAD $1188 +HST CAD | REGISTER
One and a half days Registration Fee Early Bird:
Till Dec. 08, 2016
Regular Price:
Dec. 09, 2016 to Jan. 24, 2017
Jan. 24, 2017 and
morning of Jan. 25 (9AM-12:15PM)
$688 +HST CAD $788 +HST CAD | REGISTER
One and a half days Registration Fee Early Bird:
Till Dec. 08, 2016
Regular Price:
Dec. 09, 2016 to Jan. 24, 2017
Afternoon of Jan. 25, 2017 (1PM-5PM)
and Jan. 26, 2017 (full day)
$688 +HST CAD $788 +HST CAD | REGISTER
Academia / Government
One and a half days Registration Fee 3 days Registration Fee
At all time (Save Over $300.00) $468 +HST CAD | REGISTER $788 +HST CAD | REGISTER

Group Registration Discount

Special group rates available for 3 or more registrants. Some restrictions apply. For more details please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Registration Fee Includes:

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.

Cancellation Policy

Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.


Course Venue and Hotel Accommodation
AAPS
Course Venue
AAPS Pharmaceutical Training Center
200 Consumers Road, Suite 200, North York, Ontario, M2J 4R4 Canada
Telephone: 416-502-AAPS (2277)
Direction

Hotel Accommodation
Hotel
Recommended nearby hotel
Delta Hotels by Marriott Toronto East
2035 Kennedy Road Toronto Ontario M1T 3G2 Canada
Hotel Front Desk: 1-416-299-1500
Guests are responsible for their own accommodations. Please call the hotel directly.
Special Room Rate
IPA has arranged a special room rate for attendees at the Delta Hotel. To reserve a room at the Delta with our group rate, please call the hotel directly and mentioned AAPS. Note guests are responsible for their own accommodations.
Direction


Day 1 Evening Wine & Cheese
Sponsored by:
Pills
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WHO WE ARE

IPA is the premier Canadian provider of training and skill development seminars, conferences, and expositions for professionals engaged in pharmaceutical, biotechnology, medical device, natural health products, cosmetics, and Allied industries.

GET IN TOUCH

IPA
Tel: (416) 410-7402
Email: enquiry@ipacanada.com

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