The majority of Regulatory Training offers information respective the European Union, the US and Japan but information about the wide range of markets covered under the expression “non-ICH” are rarely provided. As representative markets for the non ICH region this module offers an overview of the regulatory requirements and challenges in the BRIC countries (Brazil, Russia, India and China) and thereby supports the optimization of the Regulatory strategy on a global level. During this module guidelines and directives are introduced, but, most importantly, beyond that we provide the participants with knowledge about the strategic considerations that are essential for the global product development and the entire life cycle management of a pharmaceutical product in the BRIC countries.

Our internationally renowned speakers will take the participants through important key issues such as:

The course aims at providing Regulatory Affairs experts both the fundamentals and sophisticated tools for successful and effective operation in the non-ICH markets.

Optimizing your regulatory strategy in the BRIC countries (Brazil, Russia, India and China) representing countries of major non-ICH markets.

Our internationally renowned speakers will take the participants through important key issues such as:

The course aims at providing Regulatory Affairs experts both the fundamentals and sophisticated tools for successful and effective operation in the non-ICH markets.

Areas that among others will be covered:

An introduction to the Non-ICH/Emerging Markets/International regions:
Why these countries?
Short introduction to the common requirements for the Non-ICH countries ie CPP’s, data, samples, administrative requirements
The regulatory environment: how it is changing? What is the role of the trade associations?  Impact of other international bodies such as ICH, WHO and what is their role in harmonisation activities?

Module:  The Regulatory Agencies:
Module objectives: A good understanding of how the regulatory agency for each of the BRIC countries is structured and functions in practice is essential in order to manage effective regulatory strategies and filings.  This module will cover the structure of the regulatory agencies, how guidelines and regulatory laws are developed and implemented, their transparency and approaches to working with industry, fee structures and how they work withother regulatory agencies, both ICH and non ICH.

Module: Market Access:
Module objectives:  The BRIC countries offer a tremendous opportunity for growth to the pharmaceutical industry, both for the large multi national companies that already have a presence in the BRIC countries and in particular for the small and mid size companies that are planning on entering the market. This module will cover the regulatory aspects of market access such as the requirements and procedures for company registration, the risks and benefits of working with a local partner, co-marketing and co-promotion, regulatory barriers to entering the country for the first time and the timelines to market entry. A’how to’ and ‘what not to do’ guide for company regulatory staff for market access.

Module: Clinical Trials Applications
Module objectives: There is a growing trend for pharmaceutical companies to manage an increasing amount of their clinical development outside of the traditional ICH countries and some countries, such as China, require local clinical trials as part of the regulatory application.  This module will cover the regulatory procedures, requirements, timelines, fee structure, ethics committees and the benefits of undertaking clinical research in the non-ICH countries.

Module: New Product Applications
Module objectives: Applications for products new to the market are the cornerstone and starting point for most regulatory activities.  This module will cover the procedures, requirements, differences to ICH, review timelines, fee structure and interactions with the regulatory agencies for small molecule, biological product and device first time applications.

Module: GMP inspections
Module objectives:  The regulatory agencies view compliance to ICH or national GMP standards to be  an essential part of the regulatory process.  This module will consider why the agencies inspect, what they look for, how frequent they are likely to inspect and what is the role of the regulatory affairs function for GMP inspections.

Module: Life cycle management – 1: Line extensions
Module objectives:  Expanding the use of a medicinal product, or improving its formulation, provides the opportunity to treat new patients and increase the market.  This module will review the regulatory procedures, requirements, timelines and fee structure for line extension applications generally and for new indications, new formulations and new routes of administration specifically.

Module: Life cycle management – 2: Post Approval Changes
Module objectives:  There are a large number of changes that can potentially impact a marketed medicinal product.  This module will cover the procedures, requirements, timelines and fee structures for manufacturing and label changes plus an overview of adverse event reporting.  Consideration will be given to major and minor changes to registered particulars and if, and when, these need to be notified/registered with the agency.

Module: Life cycle management – 3: Generic Applications
Module objectives:  Generic products are important to each of the BRIC countries and important to the industry.  Many of the largest research based pharmaceutical companies have, or are looking to, develop a presence on generic products in the BRIC countries.  This module will review the procedures, requirements, timelines and approaches to generic applications by the regulatory agencies.

Module: Regulatory Intelligence
Module objectives:  The effective management of regulatory intelligence is essential in order for a company to most effectively handle its regulatory applications.  This module will review the best sources for regulatory intelligence, the value of the agency website, role of local and international trade associations and consider how the regulatory environment is changing – what will the future look like?

Lecturers:
Natalia Morgunova
Head of Regulatory, Safety and Quality subdpt., Regulatory Affairs, Safety & Quality subdpt., Novo Nordisk LLC, Moscow, Russia

Tatiana Gaban
Regulatory Affairs Manager, Produtos Roche Químicos e Farmacêuticos S.A., Sao Paulo, SP, Brazil

Estelle Patricia Michael
Senior Manager, Regulatory Policy and Intelligence, GlaxoSmithKline Biologicals, Belgium

Sukanya Choudhury
Senior Regulatory Affairs Manager, GlaxoSmithKline Pharmaceuticals Ltd., Mumbai, India

Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis.