REEP Annual Symposium and Networking Event - Agenda

Overview

The Annual REEP one day symposium is aimed at providing an educational and networking platform for exchanging thought provoking ideas, debates, and latest cutting edge topics under the Regulatory umbrella in a COST-EFFECTIVE MANNER. SMEs, hiring managers, leaders, and recruiters will be teaming up to share their insights and current trends in the regulatory field.

Learning Objectives:

At the completion of this symposium, participants can expect to:

  • Understand the holistic Global Regulatory landscape
  • Describe emerging favorable advancements in Cell and Gene therapy and regulatory approaches
  • Discuss FDA’s latest stance on “Approved Label” and compliant communications
  • Describe trends in data integrity and compliance
  • Comprehend EU MDR and its implications for Medical Devices
  • Comprehend the Regulatory Challenges of 3D Printing and Software as Medical Devices
  • Understand the Regulatory Framework of three of the most challenging countries Brazil, Mexico, and Peru

Who Should Attend?

Early and Senior Professionals from Regulatory Affairs, Quality, Clinical, Compliance, Research & Development, Marketing, Sales, and Healthcare organizations

RAC Credits

This event is eligible for six (6) RAC credits

Agenda

Time Topics
8:30–9:30 am Registration and Breakfast
9:30–9:45 am

Welcome and Introductions (Room: STC 145)

Andrew Peterson, PharmD, PhD, The John Wyeth Dean, Mayes College of Healthcare Business & Public Health, University of the Sciences, Philadelphia, PA

Suchitra Basu, PhD, RAC, RAPS Philadelphia Co-Chair, Global Strategy Manager, Regulatory Affairs, DePuy Synthes (Companies of J&J)

9:45–10:30 am

Keynote Presentation (Room: STC 145)

Disruptive Innovation in the Regulatory Affairs Paradigm: New frontiers for the Modern RA Organization”
Anton Mihic, PhD; Engagement Manager, McKinsey & Company

10:30–11:00 am

Break to visit Recruiters/Booth

11:00 am–12:00 pm

Medical Device and IVD Track (Room: STC 237)

International Regulatory Essentials for Medical Devices & IVDs in Brazil, Mexico, Peru, and Columbia
Rene van de Zande, President & CEO, Emergo group
- Key regulatory framework for Medical Devices/IVDs in  LATAM countries
- Overview of harmonization efforts through IMDFR initiatives

Biologics-Drugs Track (Room: STC 145)

Current Expectations and Guidance, including Data Integrity and Compliance With CGMP
CDR Gayle Lawson, Pre-Approval Manager & Primary Field
Alert Report Monitor, FDA Philadelphia District Office

12:00–1:00pm  Grab and Go Lunch; Meet with Recruiters (Atrium and STC 137)
1:00–2:00pm

Medical Device and IVD Track (Room: STC 237)

EU MDR and IVDR
Tamas Borsai, Division Manager TÜV SÜD
- Key changes coming under MDR & IVDR

Biologics-Drugs Track (Room: STC 145)

Going Beyond the FDA Approved Label - Stepping where Angels fear to Tread
Dr. Darshan Kulkarni, PharmD, MS, Esq.
-Discuss in depth FDA guidance documents from Jan 2017 on off-label communications for drugs and devices
- What and What not to say- The rules of communication!

2:00–2:15pm

Break

2:15–2:45pm

Medical Device and IVD Track (Room: STC 237)

3D Printing Technology
Farah Tabibkhoei, JD, Associate, Reed Smith LLP
Matt Jacobson, Associate, Reed Smith LLP
- Overview of Medical Device 3D Printing
- Regulatory Framework and Issues Concerning 3D Technology

2:15–3:15pm

Biologics-Drugs Track (Room: STC 145)

Foreign Health Authority Case Study: Health Canada Review Pathways Data Protection
Matthew Boyd,  VP, Head of Regulatory Affairs, North America
Swedish Orphan Biovitrum AB (Sobi)
- How to gain access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable in US and oUS markets (focus on Canada)
-  Discussions on the SRTD pathway (which is like 505b2 in the US)
-  Importance of Data Protection and Regulatory Strategies around these circumstances
-  The case could be set up talking about the regulations, the situation and then ask the audience to discuss in small groups to come up with what they thought was the outcome

2:45–3:15pm

Medical Device and IVD Track (Room: STC 237)

Software as a Medical Device 
Michael Zagorski (RAC, CQE, CQA), Director of Regulatory Affairs,  ImPACT Applications
- Brief overview of the regulations and requirements for stand-alone software medical device in the United States.
- Considerations and practical information on the regulatory strategies, quality system implementation and software development in regulatory environment

3:30–4:15pm

Afternoon Plenary Session (Room: STC 145)

Delivering Cell and Gene Therapy: One Big Pharma’s Approach
Dr. Joseph Tarnowski, Ph.D, Senior Vice President of Cell and Gene Therapy Platforms, PTS, R&D at GlaxoSmithKline (GSK)
 - Recent clinical successes, cell and gene therapy (CGT) is emerging as a promising approach to near personalized medicines.  Genetically engineered cells as a medical modality are poised to stand alongside or in combination with small molecule and biopharmaceutical approaches to bring new therapies to patients globally.  A recent example is GSK’s approval of Strimvelis™ the first approved ex vivo cell/gene therapy for treating ADA-SCID.
 - Role of big pharma in industrializing CGT by focusing on diseases with high un-met medical need and compelling genetic evidence.  Pharma should invest in manufacturing and supply chain solutions that deliver reproducible, high quality therapies at a commercially viable cost.  Due to the fast pace of innovation in this field, proactive engagement with regulators is critical to ensure patient safety, introduce manufacturing improvements, and modernize methods for testing quality.  It is also vital to understand the needs of patients all along the patient care pathway and establish product pricing that prescribers, payers, and patients accept.   This is particularly important in order to reach patients all over the world by delivering innovative, robust and durable CGT products that transform patient lives and eventually used to treat diseases that are more common.

4:15–4:20pm

Closing Remarks

4:20–5:30pm

Wine and Cheese Reception and Exclusive time with Recruiters (Atrium)

Contact:

Andrew Peterson, PharmD, PhD
The John Wyeth Dean and Chair, Department of Health Policy and Public Health

Address:

Office Location: FOW, Room 115
University of the Sciences
600 South 43rd Street
Philadelphia, PA 19104-4495

Phone:

215-598-7616

Email:

mayesdean@usciences.edu