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Agenda

Team Collaboration • Documentation • Data Standards • Submissions • Presentations

April 26-27, 2018
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

DAY ONE Thursday, April 26, 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

8:45

Navigate the Role of Patient Representatives and Consumer Representatives at Advisory Committees

Jennifer McNary
Board Member
Beauhawks Foundation; Manager, J McNary Consulting

Practical Models to Effectively Prepare for Advisory Committees

9:30

Leading Frameworks for Timeline Management

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

10:15

Networking and Refreshment Break

10:45

Part I. Establish a Strong Internal and External Team to Optimize Outcomes

Part II. PARTNERSHIP PAVILION The A-Team —
Aligning Clinical, Regulatory, Safety, Medical and Marketing Teams

MODERATOR:

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

PANELISTS:

Stephanie DeChiaro, RAC
Director, Regulatory Affairs
Novo Nordisk Inc.

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Dr. Steven M. Weisman
Head of Clinical and Regulatory Support
Innovative Science Solutions LLC

12:15

Networking Luncheon

Navigate Regulatory Updates and Standards

1:30

Using Standards to Simplify FDA Review Process for Devices

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

2:15

GLOBAL AND U.S. SUBMISSIONS Documentation and Writing Best Practices for Regulatory Submissions

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation and Industry Representative
FDA Advisory Committee Neurological Devices Panel

3:00

Networking and Refreshment Break

3:30

Effective Strategies for Clear and Concise Presentations

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

4:15

Navigate the Advisory Committee Preparation from the Safety and Pharmacovigilance Standpoint

Kevin P. Malobisky, PhD, MS, RAC
Senior Vice President, Regulatory Affairs, Quality and Pharmacovigilance
Karyopharm Therapeutics Inc

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Friday, April 27, 2018

7:45

Continental Breakfast

8:15

Chairperson’s Review of Day One

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

8:30

RECENTLY APPROVED PRODUCT SPOTLIGHT Inside Look at Novo Nordisk’s Semaglutide

Stephanie DeChiaro
Director Regulatory Affairs
Novo Nordisk Inc.

9:15

Examine the FDA Advisory Committee Selection Process to Understand the Backgrounds of Advisory Committee Members

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation and Industry Representative
FDA Advisory Committee Neurological Devices Panel

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

10:00

Networking and Refreshment Break

10:30

EXPERIENTIAL LEARNING Advisory Committee Mock Panel Simulation and Q&A

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Jennifer McNary
Board Member
Beauhawks Foundation; Manager, J McNary Consulting

Catherine Carlisle Leonard
Communications Lead
3D Communications

12:00

Networking Luncheon and Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Thursday, April 26, 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

8:45

Navigate the Role of Patient Representatives and Consumer Representatives at Advisory Committees

Jennifer McNary
Board Member
Beauhawks Foundation; Manager, J McNary Consulting

Practical Models to Effectively Prepare for Advisory Committees

9:30

Leading Frameworks for Timeline Management

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

10:15

Networking and Refreshment Break

10:45

Part I. Establish a Strong Internal and External Team to Optimize Outcomes

Part II. PARTNERSHIP PAVILION The A-Team —
Aligning Clinical, Regulatory, Safety, Medical and Marketing Teams

MODERATOR:

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

PANELISTS:

Stephanie DeChiaro, RAC
Director, Regulatory Affairs
Novo Nordisk Inc.

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Dr. Steven M. Weisman
Head of Clinical and Regulatory Support
Innovative Science Solutions LLC

12:15

Networking Luncheon

Navigate Regulatory Updates and Standards

1:30

Using Standards to Simplify FDA Review Process for Devices

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

2:15

GLOBAL AND U.S. SUBMISSIONS Documentation and Writing Best Practices for Regulatory Submissions

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation and Industry Representative
FDA Advisory Committee Neurological Devices Panel

3:00

Networking and Refreshment Break

3:30

Effective Strategies for Clear and Concise Presentations

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

4:15

Navigate the Advisory Committee Preparation from the Safety and Pharmacovigilance Standpoint

Kevin P. Malobisky, PhD, MS, RAC
Senior Vice President, Regulatory Affairs, Quality and Pharmacovigilance
Karyopharm Therapeutics Inc

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Friday, April 27, 2018

7:45

Continental Breakfast

8:15

Chairperson’s Review of Day One

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

8:30

RECENTLY APPROVED PRODUCT SPOTLIGHT Inside Look at Novo Nordisk’s Semaglutide

Stephanie DeChiaro
Director Regulatory Affairs
Novo Nordisk Inc.

9:15

Examine the FDA Advisory Committee Selection Process to Understand the Backgrounds of Advisory Committee Members

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation and Industry Representative
FDA Advisory Committee Neurological Devices Panel

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC; Industry Representative
FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

10:00

Networking and Refreshment Break

10:30

EXPERIENTIAL LEARNING Advisory Committee Mock Panel Simulation and Q&A

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Jennifer McNary
Board Member
Beauhawks Foundation; Manager, J McNary Consulting

Catherine Carlisle Leonard
Communications Lead
3D Communications

12:00

Networking Luncheon and Close of Conference