DIA2013 offers a custom-fit leadership approach for women in middle-management RA and legal functions.

The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions

This interactive workshop will be held June 23 from 1:00 - 6:00PM in Boston, MA and is designed to improve leadership agility and performance. You will learn how executives in these functions express their value and will work with tools to help them identify and articulate their own unique value to their business partners within the pharmaceutical, biotechnology, and medical device industry. The new insights and leadership skills gained at the workshop will be immediately applicable in the work setting.

Instructors:
Welcome & Opening Remarks
Minnie Baylor-Henry, JD, RPh, DIA President Elect
Worldwide Vice President, Regulatory Affairs
Johnson & Johnson Medical Devices & Diagnostics

Session 1: Industry Trends and Key Criteria for Business Success in Today’s Environment

Session 2: Business Acumen: Framing Your Role with a Business Context
Ilyssa Levins, Winner of HBA President’s Award and Rising Star
President
Center For Communication Compliance (CCC)

Session 3: Moving from Technical to Strategic Thinking
Catherine Angell Sohn, PharmD, HBA Women of the Year
Dean's Professor; President, Sohn Health Strategies LLC
University of the Sciences

Networking Break

Session 4: Commanding Executive Presence
Karen Hough, Nationally Recognized Author
Founder and CEO
ImprovEdge, LLC

Session 5: Working with or as a Mentor
Hayley A. Norman, Author and Former Pharmaceutical Executive
Managing Member
Metajourn, LLC

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

What are the best practices for Clinical Trial design, agency interactions and regulatory document writing?

Successful Drug Development:
Best Practices for Clinical Trial Design,Agency Interactions and Regulatory Document Writing
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples that illustrate approaches to adopt or to avoid.

Instructor(s):
Elaine B. Taylor ,
Associate Director, Regulatory Strategy, Consulting, and Submissions
INC Research, United States

Kathy Wekselman,
Director, Regulatory and Scientific Affairs
CTI Clinical Trial and Consulting Services, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

6th Regulatory Conference - India - April 5-6

Hear from prominent presenters on the latest regulatory issues Rajiv Gulati President Global Pharmaceuticals Business, Ranbaxy Laboratories Limited G. N. SinghDCGI (Drug Controller General of India) High-profile speakers and attendees will discuss the challenge of ever-evolving regulation at the 6th Regulatory Conference in India. The conference, to be held in Ahmedabad, Gujarat from April 5-6, will feature keynote speaker Rajiv Gulati, President Global Pharmaceuticals Business, Ranbaxy Laboratories Limited, presenting on the theme “India, the Upcoming Economy: Encouraging Enforcement of Regulations.” Also participating will be the Drug Controller General of India (DCGI), Dr. G. N. Singh. The two-day event will bring together prominent industry experts, senior management professionals, academicians and regulators to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharmaceutical industry. Read More Register Other events of Interest Download the India Calendar of Events Who Should Attend Professionals in: Regulatory Affairs from Government and Industry Clinical Research and Development Safety and Pharmacovigilance Clinical Trial and Project Management CMC/Quality (Quality, Manufacturing and Controls) QA and QC Product Development Read More Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partners

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LARC2013 Join the collaboration for improved regulation

Join the collaboration for improved regulation Registration is now open for the Latin American Regulatory Conference (LARC) 2013. Join global regulators, industry professionals and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16. The event will focus on “Pharma-Co-Vergence” – the act of achieving pharmaceutical regulatory convergence through stakeholders’ collaboration – highlighting the true collaborative spirit of this multidisciplinary global conference. Attendees will learn how to define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America, and discuss the progress of the Pan American Network for Drug Regulatory Harmonization (PANDRH) convergence process and working groups. Read More Register 2012 VIDEO HIGHLIGHTS Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013. IT ONLY TAKES A FEW MINUTES... Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest. Featured Topics Regulatory Landscape and Convergence Initiatives Strengthening the Regulatory Framework Efforts Underway by Convergence Initiatives Reviews and Inspections Ethics Committee Research in the Regions Post-market Research Studies and Better Medicines to Influence Efficacy and Effectiveness Perspectives and Regulations of Pediatric Studies Drug Safety, Marketing Surveillance and Quality Control Monitoring Regulatory Concerns: Health Systems and Security of the Supply Chain Current Regulations of Biologics and Biosimilars Emerging Topics Who Should Attend Professionals involved in: Regulatory affairs Clinical research and development Clinical safety and pharmacovigilance Clinical trial and project management Drug development and discovery Medical and scientific affairs Preclinical development Quality assurance Research and development Strategic sourcing/planning Read More Register

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Obama Administration Weighs Options In Face Of Marijuana Legalization.

The New York Times (12/7, Savage, Subscription Publication) reports, "Even as marijuana legalization supporters are celebrating their victories in the two states, the Obama administration has been holding high-level meetings since the election to debate the response of federal law enforcement agencies to the decriminalization efforts." The question of which actions the federal government will take is a complex one, with marijuana legalization being popular with Obama's base. In addition, according to federal officials who spoke on condition of anonymity, issues raised include "enforcement priorities, litigation strategy and the impact of international antidrug treaties," because marijuana is still illegal at the Federal level. Current federal policy calls for using resources to go after "large-scale trafficking organizations. The result has been more federal raids on dispensaries than many liberals had expected."

        USA Today/Gallup: Feds Should Leave Legal Marijuana In States Alone. USA Today (12/7, Page) reports that, while Americans are almost evenly divided on the legalization of marijuana "those surveyed say by almost 2-1, 63%-34%, that the federal government shouldn't take steps to enforce federal marijuana laws in states that legalize pot." USA Today adds, "Still unclear is precisely how, and how aggressively, federal law enforcement officials plan to proceed."

        Colorado Groups Ask Attorney General To Enforce Federal Marijuana Law. CNN (12/5, Duke) reports on its website that in Colorado, where marijuana use will become legal in less than a month, 20 business groups have asked Attorney General Eric Holder "to enforce federal pot laws, because of questions about how to deal with workers who are high." According to Sandra Hagen Solin, of the Northern Colorado Legislative Alliance, "There is uncertainty about our ability to terminate employees if they come to the job impaired. ... There are obligations that we have under the drug-free workplace. There are a lot of questions that have arisen."

        First New Jersey Marijuana Dispensary Opens. The New York Times (12/7, Hartocollis, Subscription Publication) reports that after being "delayed by political battles over whether it would lead to the de facto legalization of marijuana," New Jersey's first medical marijuana dispensary has opened. "Provided a doctor's prescription for a list of specified medical conditions was presented," to the owners of the store, purchasing the marijuana would be legal under state law. The Greenleaf Compassion Center is described as "like an upscale doctor's office," by one of the business partners, Julio Valentin, Jr.

        The Philadelphia Inquirer (12/6, Hefler) notes, "Five other dispensaries, including one in Egg Harbor, Atlantic County, have been preliminarily approved by the state." The New York Daily News (12/7, Brown), and NJ.com (12/7) are among the media outlets also reporting on the New Jersey dispensary.

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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FDA/CDRH Device Good Manufacturing Practice Advisory Committee (DGMPAC) -Docket No. FDA-2012-N-0001

The FDA's looking for a few good medtech members

 

from MassDevice - FDA and Medical device business news and jobs for the medical device industry by MassDevice staff

The FDA solicits candidates for medical device industry representatives to join the Center for Devices & Radiological Health's Device Good Manufacturing Practice Advisory Committee.

The FDA is seeking written recommendations for candidates to sit on the Center for Devices & Radiological Health's Device Good Manufacturing Practice Advisory Committee, according to a note in the Federal Register.
The federal watchdog agency asked for written recommendations of medical device industry representatives who will hold a non-voting seat on the DGMPAC, a committee tasked with reviewing proposed regulations and making recommendations on medical device manufacturing practices.

-----------------------------------------------------------------------
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[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71804-71805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29165]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Device Good Manufacturing Practice Advisory
Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) in the Center for
Devices and Radiological Health notify FDA in writing. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
current vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting members to represent industry
interests must send a letter stating that interest to FDA by January 3,
2013, for the vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by January
3, 2013.

ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993, 301-796-
5960, margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as amended, provides that the DGMPAC
shall be composed of two representatives of interests of the device
manufacturing industry. The Agency is requesting nominations for
nonvoting industry representatives on the DGMPAC.

I. Function of DGMPAC

    Review proposed regulations issuance regarding good manufacturing
practices governing the methods used in, and the facilities and
controls used for manufacture, packaging, storage, installation, and
servicing of devices, and make recommendations regarding the
feasibility and reasonableness of those proposed regulations. The
committee also reviews and makes recommendations on proposed guidelines
developed to assist the medical device industry in meeting the good
manufacturing practice requirements, and provides advice with regard to
any petition submitted by a manufacturer for an exemption or variance
from good manufacturing practice regulations.

II. Qualifications

    Persons nominated for the DGMPAC should possess appropriate
qualifications to understand and contribute to the committee's work as
described in the committee's function.

[[Page 71805]]

III. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular committee. The interested organizations are
not bound by the list of nominees in selecting a candidate. However, if
no individual is selected within the 60 days, the Commissioner of Food
and Drugs will select the nonvoting member to represent industry
interests.

IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from device manufacturing industry.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29165 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P

FDA / CDRH 2013 Strategic Priorities released

Link to: CDRH 2013 Strategic Priorities

The Center for Devices and Radiological Health's (CDRH, the Center) 2013 Strategic Priorities continue and expand upon the work we first started three years ago to reset the direction of the Center towards smart regulation – protecting public health by assuring that devices that enter and remain on the U.S. market are safe and effective, and promoting public health by facilitating device innovation. However, the structure of this year's Strategic Priorities has been re-organized to align with CDRH's Vision, which, along with our Mission and Shared Values, immediately follow this Introduction. You will note that our Vision begins with the word Patients. We intentionally began our Vision with this word because what is at the heart of what we do and what we truly are about is saving the lives, improving the health and enhancing the quality of life of patients and those who one day will or would have been patients.

Although we have re-aligned our Strategic Priorities to support the achievement of our Vision, you will see that the objectives of our 2010-2012 Strategic Priorities² (such as fully implementing a total product life cycle approach) are encompassed within our 2013 plan. In addition, we have kept our earlier Strategic Priority of Strengthening Our Workforce and Workplace in the 2013 plan, consistent with the Center's Shared Value of Our People. A vibrant workforce and workplace are essential to achieving our Mission and Vision.

The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year. It is not intended as a comprehensive blueprint of every action the Center may take in the coming months.

Lastly, in July 2012, Congress enacted the Food and Drug Administration Safety and Improvement Act (FDASIA)³, which includes reauthorization of the medical device user fee program⁴ and other device-related provisions. We consider implementation of FDASIA to be a top priority for CDRH. Therefore, as a well understood priority, we will implement or begin to implement all of the device-related provisions of FDASIA this year. However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities.

Link to: CDRH 2013 Strategic Priorities

Regulatory Convergence and Cooperation to Improve Access and Quality -Singapore

Regulatory Conference Program Now Available! To kick off 2013, the Asia Regulatory Conference is bringing together global regulatory professionals to share past experiences and new practices. Don’t miss this exciting event to interact with regulatory and other professionals! OVERVIEW Join health authority representatives and industry professionals from Asian and ICH member countries as they continue to discuss regulatory aspects of ICH, APEC and ASEAN convergence initiatives, good regulatory practices, quality and GMP, global drug development, and pharmacovigilance. OBJECTIVES This three-day conference offers a unique opportunity for key stakeholders from health authorities, local and multinational pharmaceutical companies, and clinical research to meet and exchange views, discuss topics of interest and identify focus areas for ongoing efforts to increase patient access to new and improved medicines. This conference will provide a forum to: • Facilitate discussion on common issues in the regulatory and technical areas in Asia • Encourage greater convergence of regulatory requirements in Asia • Strengthen cooperation between Asian regulatory authorities and pharmaceutical industry Day One – Research and Development Day Two – Good Regulatory Practices Day Three – 21st century Global Regulatory Challenges   Register Online     Program Overview     View PDF Program committee chairs Arun Mishra Director Global Regulatory Affairs GlaxoSmithKline, UK John C.W. Lim Chief Executive Officer Health Sciences Authority, Singapore  Who Should Attend Representatives of Health Authorities, Regulatory Affairs professionals, and other professionals involved in or interested in the aspects surrounding registration of medicinal products and regulatory convergence initiatives in Asia. Ministries of Health and Medicines Regulatory Authorities Regulatory Affairs Clinical Research and Development Safety and Pharmacovigilance Clinical Trial and Project Management CMC/Quality (Quality, Manufacturing and Controls)   Register Online     Program Overview     View PDF To know more contact Ellen.Diegel@diahome.org.