Regulatory Strategy Summit-II
August 2015, Zurich, Switzerland
Advance Therapeutic Products – A Roadmap for Current Opportunities and Challenges
It is critical for companies developing drugs, biologics, medical devices and diagnostic kits to master the art of getting consultation from the regulators at the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and their counterparts in each country. Regulators provide an opportunity to the industry to discuss product development strategies and clarify interpretations of the regulations prior to submission of applications to them for approval. Besides meetings, regulators also interact via emails, phone calls and in-formal discussions. This conference aims to bring regulators, industry and other stakeholders together to discuss the various ways to obtain advice from regulators, discuss feedback, and present ideas to increase the odds of successful outcome of approval.
Agenda
Day 1: 6 May 2015: Pre-Conference Mini-Workshops
09:00 – 12:00 Workshop I: How to strategize and prepare a meeting information package for FDA
13:00 – 16:00 Workshop II: How to prepare a global regulatory strategy plan
Day 2: 7 May 2015
8:00 – 9:00 Registration, Breakfast and networking
9:00 – 9:10 Welcome
9:10 – 9:40 Opening Keynote Session: Strategy of Meeting with Govt Officials
09:40 – 10:00 Break
10:00 –11:15 Session I: Interactions with CDRH, FDA, for medical device development and approval
Practical aspects of meeting US FDA for discussing development of new medical devices, jurisdiction over medical devices, designation of combination products, new approval pathways for US market.
11:15 - 12:30 Session II: Regulatory Challenges for Industry in a Global Environment
Discussion on Business and regulatory strategies in the global setting, key regulatory challenges for industry in interacting with the different global agencies, and managing products in a global environment, global regulatory strategies.
12:30 – 13:30 Lunch
13:30 – 15:00 Session III: Meetings and interactions with National Regulatory Authorities in Europe
Practical aspects of interacting with Notified Bodies
15:00 – 16:30 Session IV: Opportunities for Interactions with regulatory agencies: How to prepare and conduct a successful meeting with the FDA and the EMA (focus drugs)
Successfully navigating the FDA’s and EMA’s drug approval processes can be challenging. A key success factor is effective, clear, and frequent communication with the agencies. During this session, the attendees will explore the agency’s perspectives on how to properly interact, and what are the agencies expectations during teleconferences and meetings. The speakers will provide examples of best practices, as well as common pitfalls, in industry-agency interactions.
16:30 – 17:00 Break
17:00 – 18:30 Reception
Day 3: 8 May 2015
08:30 – 09:45 Session V: Dealing with challenging issues during an inspection – how to interact with agencies effectively under pressure
During this interactive session, the attendees will be divided in small groups. They will be engaged in a discussion and asked how they would respond to challenging events before and during an inspection. Then a panel on experts will provide their insights and advice.
10:00 – 10:30 Break
10:30 – 12:45 Session VI: How to Prepare for a meeting with US FDA
This session will discuss the process of requesting FDA meetings, the preparation of a meeting information package, the logistics and format of the meeting, the dos and don’ts of the meeting, meeting outcome and minutes
12:45 – 13:45 Lunch
13:45 – 15:00 Session VII: Collaborative Partnerships: Accelerating the Translation from the Bench to the Bedside
15:00 - 16:30 Session VIII: Disputes Resolution meetings with FDA
This session will discuss FDA guidance documents on dispute resolution with its reviewers, best practices to address disagreements with data analysis from clinical trials, product designation, advisory committees, best practices to get FDA on your side and rules for dispute resolutions with FDA
16:30 – 17:15 Closing Keynote:
17:15 Adjorn
August 2015, Zurich, Switzerland
Advance Therapeutic Products – A Roadmap for Current Opportunities and Challenges
It is critical for companies developing drugs, biologics, medical devices and diagnostic kits to master the art of getting consultation from the regulators at the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and their counterparts in each country. Regulators provide an opportunity to the industry to discuss product development strategies and clarify interpretations of the regulations prior to submission of applications to them for approval. Besides meetings, regulators also interact via emails, phone calls and in-formal discussions. This conference aims to bring regulators, industry and other stakeholders together to discuss the various ways to obtain advice from regulators, discuss feedback, and present ideas to increase the odds of successful outcome of approval.
Agenda
Day 1: 6 May 2015: Pre-Conference Mini-Workshops
09:00 – 12:00 Workshop I: How to strategize and prepare a meeting information package for FDA
13:00 – 16:00 Workshop II: How to prepare a global regulatory strategy plan
Day 2: 7 May 2015
8:00 – 9:00 Registration, Breakfast and networking
9:00 – 9:10 Welcome
9:10 – 9:40 Opening Keynote Session: Strategy of Meeting with Govt Officials
09:40 – 10:00 Break
10:00 –11:15 Session I: Interactions with CDRH, FDA, for medical device development and approval
Practical aspects of meeting US FDA for discussing development of new medical devices, jurisdiction over medical devices, designation of combination products, new approval pathways for US market.
11:15 - 12:30 Session II: Regulatory Challenges for Industry in a Global Environment
Discussion on Business and regulatory strategies in the global setting, key regulatory challenges for industry in interacting with the different global agencies, and managing products in a global environment, global regulatory strategies.
12:30 – 13:30 Lunch
13:30 – 15:00 Session III: Meetings and interactions with National Regulatory Authorities in Europe
Practical aspects of interacting with Notified Bodies
15:00 – 16:30 Session IV: Opportunities for Interactions with regulatory agencies: How to prepare and conduct a successful meeting with the FDA and the EMA (focus drugs)
Successfully navigating the FDA’s and EMA’s drug approval processes can be challenging. A key success factor is effective, clear, and frequent communication with the agencies. During this session, the attendees will explore the agency’s perspectives on how to properly interact, and what are the agencies expectations during teleconferences and meetings. The speakers will provide examples of best practices, as well as common pitfalls, in industry-agency interactions.
16:30 – 17:00 Break
17:00 – 18:30 Reception
Day 3: 8 May 2015
08:30 – 09:45 Session V: Dealing with challenging issues during an inspection – how to interact with agencies effectively under pressure
During this interactive session, the attendees will be divided in small groups. They will be engaged in a discussion and asked how they would respond to challenging events before and during an inspection. Then a panel on experts will provide their insights and advice.
10:00 – 10:30 Break
10:30 – 12:45 Session VI: How to Prepare for a meeting with US FDA
This session will discuss the process of requesting FDA meetings, the preparation of a meeting information package, the logistics and format of the meeting, the dos and don’ts of the meeting, meeting outcome and minutes
12:45 – 13:45 Lunch
13:45 – 15:00 Session VII: Collaborative Partnerships: Accelerating the Translation from the Bench to the Bedside
15:00 - 16:30 Session VIII: Disputes Resolution meetings with FDA
This session will discuss FDA guidance documents on dispute resolution with its reviewers, best practices to address disagreements with data analysis from clinical trials, product designation, advisory committees, best practices to get FDA on your side and rules for dispute resolutions with FDA
16:30 – 17:15 Closing Keynote:
17:15 Adjorn
