Navigation Links
Healthcare Product Regulatory Professionals to Convene in Boston for RAPS Annual Conference & Exhibition
Date:9/10/2008

ROCKVILLE, Md., Sept. 10 /PRNewswire-USNewswire/ -- Regulatory professionals from more than 25 countries will converge on Boston next week for the Regulatory Affairs Professionals Society's (RAPS) 2008 Annual Conference & Exhibition. The annual event is the largest of its kind exclusively for regulatory professionals in the healthcare product sector.

The regulatory profession encompasses a wide range of professional titles and job responsibilities related to ensuring that healthcare products in areas such as medical devices, biologics and pharmaceuticals are safe and effective and comply with all applicable government regulations. The 2008 RAPS Annual Conference & Exhibition, the theme of which is "Leadership in Motion," will take place at Boston's Hynes Convention Center, 14-17 September.

"This is a very exciting time to be in the healthcare product regulatory profession as the profession continues to grow in its influence and recognition," said RAPS Executive Director Sherry Keramidas, PhD, CAE. "From research and development though clinical trials, marketing and product surveillance, regulatory professionals play important roles at every stage. With the rapid pace of new medical and healthcare technology, the changing global regulatory landscape and the increased attention to the role that regulatory concerns play throughout the healthcare product lifecycle, this year's RAPS Annual Conference & Exhibition promises to be an important one to watch for anyone concerned with developing and disseminating life-saving and life-enhancing products."

Among the topics to be examined at the conference are safety issues in clinical trials; the evolving regulatory environment in China, India, Southeast Asia and other emerging regions, and the impact on the global healthcare product market; postmarket clinical registries; drug anti-counterfeiting strategies; environmental regulations' impact on drug development; and pediatric drug development. The overarching theme of leadership will be discussed at sessions throughout the conference.

Senior officials from the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and other top regulators will update attendees on the latest developments from their respective agencies. Attendees also will hear from prominent keynote speakers in medicine, media and business.

Following are some conference highlights. For more information and a complete listing of conference events, visit http://www.raps.org/ac2008.

Monday, 15 September

8:30-10:00 am

Keynote: Dr. Atul Gawande, practicing surgeon, writer and best-selling author

11:00 am-12:00 pm

Regulatory Hot Topics Overview: Asia

Overview of the diverse, rapidly evolving regulatory structure and processes of China, India and Southeast Asia.

Tuesday, 16 September

8:30-10:00 am

Keynote: Dr. Joseph L. Bower, Baker Foundation Professor, Harvard Business School

11:00 am-12:00 pm

Seeking Balance: Regulation, Innovation and Cost-Containment of Orphan Biopharmaceuticals

Examination of the current regulatory landscape of orphan drugs from both US and EU perspectives.

1:30-3:00 pm

Postmarket Clinical Registries

Usage of clinical registries has increased, providing more information for postmarket surveillance and altering expectations for medical devices.

3:30-5:00 pm

Emerging Safety Issues in Clinical Trials

Recent drug recalls and media coverage of safety concerns have heightened the political climate in which regulators operate. What are the emerging safety issues in clinical trials?

Product Testing and China's Regulatory Environment

Regulations for medical devices in China are evolving continuously. Speakers will discuss expected changes for product testing and their potential impact on the global marketplace.

Wednesday, 17 September

8:30-10:00 am

Food and Drug Administration Amendments Act of 2007: One Year Later

The Food and Drug Administration Amendments Act (FDAAA) of 2007 presented some of the biggest changes to US medical device and pharmaceutical regulation in perhaps 10 years. Speakers will review implementation accomplishments and expectations, nearly a year later, as well as discuss future challenges for FDAAA.

12:00-2:00 pm

Keynote: Dr. Holly Atkinson, prominent healthcare journalist

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. http://www.raps.org


'/>"/>
SOURCE Regulatory Affairs Professionals Society (RAPS)
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. SSI Announces Agreement with Siemens Healthcare
2. Allsup's New Medicare Advisor Program Helps People with Disabilities Make Sound Healthcare Coverage Decisions
3. Baird Hosts Small Cap Health Care Conference : Senior Healthcare Distribution & Services Research Analyst Eric Coldwell Shares Insights on Sector
4. Healthcare Executive Richard Peitzmeier Returns to Phoenix as Regional Sales Director of SCAN Health Plan Arizona
5. Conventions Conclude, Fall Campaign Begins: NFIB Looks for More Focus on Small Business Healthcare Concerns
6. ULURU Inc. to Present at the Thomas Weisel Partners Healthcare Conference 2008
7. Demystifying Medicare and Long Term Care Insurance - Healthcare Liaison Workshop 9/20 Shows Consumers How to Make Choices
8. MBF Healthcare Acquisition Corp. Amends Stock Purchase Agreement With Critical Homecare Solutions Holdings, Inc. to Extend Termination Date to October 31, 2008
9. LodgeNet Healthcare Expands Into Hawaii Through Agreement With St. Francis Hospice
10. WellSpring Pharmaceutical Corp. Acquires Consumer Product Brands from McNeil Consumer Healthcare -- Deal Enhances US and Canadian Pharmaceutical Business
11. Photos: Perot Systems Expands Healthcare Market Initiatives with Launch of Revenue Cycle Solutions Ad Campaign
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... The Radiology Business ... Awards . The annual awards, now in their 12th year, are among the most ... winners. , In 2016, the awards were retooled to recognize achievements in both large ...
(Date:3/24/2017)... Lake Orion, MI (PRWEB) , ... March 24, ... ... providing insurance assistance, financial planning, and related services to families and business owners ... charity initiative aimed at feeding regional families struggling with financial difficulties. , The ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... they are now offering treatments for sleep apnea and TMJ at their office. ... Sleep apnea , specifically the obstructive type, is increasingly being treated at dental ...
(Date:3/24/2017)... ... March 24, 2017 , ... Gastro Health (“GH”) ( ... patients for colonoscopy at the HyGIeaCare® Center that is to be located adjacent ... , The HyGIeaCare® Prep, cleared by the U.S. Food and Drug Administration ...
(Date:3/24/2017)... ... ... Time GPS”: a dauntless and enlightened study of the second-coming of Christ, and ... published author, Wesley Gerboth, a World War II veteran, with a highly-regarded reputation as ... ninety-one, he shares the Wisdom God bestowed upon him in this publication. , ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... DUBLIN , Mar. 24, 2017 ... "Pain Management in the U.S.: Consumer Strategies" report to ... ... on how adults approach and treat their physical pain, emphasizing ... two distinct groups: pain sufferers and adults who have selected ...
(Date:3/24/2017)... 2017   The Accreditation Council for Medical ... in the pharmaceutical industry has appointed Dr. ... newly formed scientific advisory board. Dr. Chin will ... first ever medical affairs think tank within the ... the ACMA, please visit  www.medicalaffairsspecialist.org .  Connect ...
(Date:3/24/2017)... YORK , March 24, 2017 ... ... a leading publisher of cannabis market research, the legal cannabis ... percent CAGR through 2021, despite conflicting signals from the current ... points out that the two biggest drivers of growth in ...
Breaking Medicine Technology: