Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Chicago, Illinois, USA.

Day 2 :

Keynote Forum

Eliana Silva de Moraes

ABPVS, Brazil

Keynote: Global regulatory challenges and implications

Time : 09:30-10:00

OMICS International Regulatory Affairs 2017 International Conference Keynote Speaker Eliana Silva de Moraes photo
Biography:

Eliana has her expertise in Food and Drug Law. She has 26 years’ experience in helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents. She has played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. She is President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes, Member of the Brazilian Bar Association and The Portugal Bar Association.

 

Abstract:

Becoming a global company is an impressive task specially to make strategic decisions for the product approval. One of huge challenges is the lack of uniform standards and regulations when selling and marketing in another country than of the product origin. It is impossible for to standardize a single application form of a product registration for different countries. Because of this the regulatory process can be costly and the product approval can take time. So, companies that intend to launch a product in an international market must think to develop a good regulatory strategy that allows dealing with each country separately (most of the time) and their regulatory staff needs to acquire knowledge to help accomplish with the regulations, locally. The purpose of this topic is to find common elements in the most varied regulatory systems that enable companies to more accurately identify the documents and information required by international regulators and understand technics that can help to reduce cost and time in the registration approval process globally. An analysis of the legislation of the different countries for the approval of registration of medical equipment and an identification the common elements will be discussed in a practical way.

 

Keynote Forum

Stephen F Amato

Northeastern University, USA

Keynote: Convergence of regulatory affairs and reimbursement/market Access

Time : 10:00-10:30

OMICS International Regulatory Affairs 2017 International Conference Keynote Speaker Stephen F Amato photo
Biography:

Stephen F Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. He is the Program Director of the Biomedical Regulatory Affairs Program in the Professional Advancement Network (PAN) at Northeastern University. Steve has also been the Managing Director of tJun 17 Life Sciences, LLC, an organization that facilitates the global commercialization of early stage medical technologies. Prior to founding and directing operations at Jun17 Life Sciences, Steve was the Executive Director of Marketing at Anika Therapeutics where he served as the Head of Anika's Marketing Department. In this role he
managed all aspects of the company's product portfolio including market segmentation, targeting, and positioning, pricing and promotional strategies. From 2000 to 2007 he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140 M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents. He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis. Steve holds an AB in Biochemical Sciences from Harvard University, a in Molecular and Cellular Biology from Boston College’s Graduate School of Arts & Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the US Regulatory Affairs Certification (RAC) designation and is a Consultant for the Regulatory Affairs Professional Society (RAPS).

Abstract:

The purpose of this study is to describe the evolution of convergence drivers between global regulatory science and reimbursement paradigms, outline the similarities and differences between 'safety and efficacy' and 'reasonable and necessary and to explain how cost effectiveness variables can be considered during evaluation of drug approval applications. In the European Union, specifically the UK and Germany, regulatory approval and reimbursement determination for biomedical products goes hand in hand. But few biomedical product companies in the US have taken advantage of the pilot programs that enable, for example, the parallel pursuit of both FDA approval and CMS national coverage determinations. These are
intended to alleviate some of the process heavy FDA and CMS requirements that the industry often views as hampering innovation. At the same time, pursuing both approvals to market and universal coverage with Medicare in parallel can seem daunting to biomedical product developers. It calls for smarter study design that matches the expectations of the FDA, CMS and private payers. That means not only focusing on clinical endpoints that prove the products to be safe and effective, but also demonstrating that the product is reasonable and necessary, and superior to others in its category. This presentation will outline both the benefits to the parallel review pilot program on the device side and the key factors device developers need to consider when pursuing a joint approval, including: Advocate for more transparency in the process – medical device
companies often shy away from opening the door to a conversation with the FDA, but in this case, dialog and gathering as much information as possible is key; establish guiding principles – timelines and expectations for both the FDA and CMS need to be clearly defined before trials begin; know when to call it quits–device developers can withdraw from the process at any time and need to see and interpret signs for decoupling the pursuit of both milestones. Through better design of the clinical development process, biomedical product manufacturers can address both regulatory science as well as payer standards during the commercialization process.