The European Commission has put in place a regulation (Article 57) mandating electronic submissions to medicinal products dictionaries for all medicinal products. In addition to creating immediate changes for the human medicines industry, this regulation is the flagship of global adoption of ISO IDMP (Identification of Medicinal Products) standards in support of ICH M5 by 2015–16.
This global convergence is creating a massive shift in regulatory. Organizations that proactively adopt practices and technology to comply with this change will benefit from the added ability of strategic decision making and dynamic resource planning. This webcast will equip regulatory professionals with the knowledge to prepare and meet the challenge of converging standards today and into the future.
Learning Level(s): Intermediate
Upon the webcast's conclusion, you should be able to:
- Understand and articulate the implications of the European Medicines Agency’s Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) regulation and ISO IDMP standards being drafted by the International Conference on Harmonisation (ICH)
- Understand the impact of the convergence of regulatory standards for medicinal products across the world to the ISO IDMP standards and its implications for regulatory departments at pharmaceutical and biotechnology companies
- Design and implement strategies to manage these large-scale changes without compromising on continuous 100% compliance
Who Should Attend:
- Senior regulatory decision makers at pharmaceutical and biotechnology companies
- Managers and other professionals who execute regulatory strategies for pharmaceutical and biotechnology companies
- Information technology and information systems managers who implement regulatory information management systems for pharmaceuticals and biotechnology companies
Wim Cypers, vice president, Aris Global LLC
Wim Cypers leads the regulatory affairs software products unit at ArisGlobal. In this role, he is responsible for the research, development and deployment of all regulatory products offered by the organization—including managing the impact of ever-changing regulatory shifts into all the products in the ArisGlobal portfolio. He is also a frequent presence at numerous regulatory events around the globe. In more than 17 years with ArisGlobal, Cypers has held various senior product and business development positions. Before joining ArisGlobal, Cypers was a project leader at Janssen Pharmaceutica, a pharmaceutical division of Johnson & Johnson Inc., based in his home country of Belgium. He is an industrial pharmacist trained at the Katholieke Universiteit Leuven, a major European center for higher learning.