Value Added Medicines / Scientific, Regulatory and IP Analysis

Place
Vienna Marriott Hotel, Vienna, Austria
Site visit
Dates
In-house Available
30 November - 2 December 2020
Who should attend?

Product portfolio planners, Business development, C-level executives, Heads of R&D, Regulatory affairs, Market access, Mergers and Acquisitions managers, Intellectual property, Pricing & reimbursement

Summary

This unique training is focusing on highly evolving areas of Value Added Medicines business development. The participants will explore the scientific, regulatory, intellectual property and clinical challenges of innovative generic portfolio design.

Learning Objectives

  • The concept of value in the health care environment
  • Analyse the market before embarking on an added value strategy
  • Create viable business models in different markets
  • Is repositioning a high-risk strategy – when could it be suitable for your company?
  • How to differentiate a generic product
  • Select the right route to drug approval
  • What type of products to stay away from because of clinical barriers
  • How to protect your investment through IP

Key Topics

  • Innovative Generic Business Development
  • A concept of value in health care environment
  • Market Access for Value Added Medicines
  • Drug Repositioning / Repurposing
  • Scientific and Technological solutions for Value Added Medicines
  • Clinical aspects
  • IP and data exclusivity
  • Formulation patents: successes and failures

Programme

All training materials will be provided in printed and digital form

All delegates will receive printed and LinkedIn certificates

Five hours of networking with industry peers

• An in-depth scientific discussion of different mechanisms that could lead to an added value product

• Selecting the right route to drug approval is an essential part of the added value process

• Case studies of Formulation patents – successes and failures

• Recent cases regarding Formulation patents and Swiss “use” patents

• Consequences of market switch from Brand to INN generics

Request Full Agenda

Trainers

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Catarina Lopes Pereira, PharmD

Global Market Access Manager

medac GmbH

Former coordinator of the value added medicines sector group at Medicines for Europe

Catarina Lopes Pereira is a Market Access specialist focused on value added medicine in EU area. MSc in Pharmaceutical Sciences by background, she obtained her master in the Faculty of Pharmacy of the University of Lisbon. Catarina joined Medicines for Europe in April 2016. As part of the Market Access team, she is working to shape in the EU a dynamic and sustainable market situation that enables fast and fair pricing & reimbursement for value added, biosimilar and generic medicines. Since November 2017, Catarina has taken over the coordination of the Value Added Medicines sector group. From 2020 Catarina is working as Global Market Access Manager at medac GmbH.

Catarina Lopes Pereira, PharmD

Global Market Access Manager

medac GmbH

Former coordinator of the value added medicines sector group at Medicines for Europe

Catarina Lopes Pereira is a Market Access specialist focused on value added medicine in EU area. MSc in Pharmaceutical Sciences by background, she obtained her master in the Faculty of Pharmacy of the University of Lisbon. Catarina joined Medicines for Europe in April 2016. As part of the Market Access team, she is working to shape in the EU a dynamic and sustainable market situation that enables fast and fair pricing & reimbursement for value added, biosimilar and generic medicines. Since November 2017, Catarina has taken over the coordination of the Value Added Medicines sector group. From 2020 Catarina is working as Global Market Access Manager at medac GmbH.

Tour info

Price per Delegate (EUR)

Public Training

2295.00

Online Training

1500.00
Register Now

Testimonials

“A great journey through generic/vale added moleculesand beyond. A must for people stepping into VAM world or already on a journey.“ 

- Julia Metzner, Head of PM Specialties & Alliance Management, Stada Arzneimittel  

“Very rich content with real world examples. Trianer is very strong in rich information/right content. Worth to take this training if your routes cross VAM development.”

- Araksya Topchyan, Global Marketing Manager Pharma, DSM 

“Malcolm has been a wonderful trainer, he has huge experience in all fields and I feel we could be going deeper in any of the subjects for hours.“

- Ruth Bielsa, R&D Pharmaceutical Scientist, Medichem 

Request Full Agenda

For the detailed agenda with a full breakdown of the individual sessions fill out this form.

Thank you! We will verify your request and contact you from this number: +420 223 014 960
Oops! Something went wrong while submitting the form. Please Contact us and we will process your request.

Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543