Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

IDMP [clear filter]
Monday, June 27
 

8:30am EDT

#117: IDMP: A Compliance Project or a New Way of Conducting Business?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA



Chair
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →

Speakers
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry... Read More →


Monday June 27, 2016 8:30am - 9:30am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session

10:45am EDT

#131: IDMP Update
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC



Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his... Read More →

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →
avatar for Tom Macfarlane

Tom Macfarlane

Director, Life Sciences, Accenture Accelerated R&D Services
A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session