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Welcome!

This is the inaugural edition of the TOPRA In North America UPDATE newsletter. We are developing this quarterly newsletter with the objective of sharing information that is relevant to North American members of TOPRA while also providing an opportunity for members to learn what our industry colleagues are doing. Our hope is that this newsletter will help facilitate additional dialogue among Regulatory professionals in North America and promote awareness of key Regulatory topics. If you would like to contribute an article or participate in the editorial team, please contact mgarrett@octagonresearch.com

TOPRA North America Leadership Team | Important Professional Resources

HEALTH CANADA NEWS

Contributed by Aman Khera, Director of Regulatory Affairs, PRA International

Changes are coming in Health Canada! The authority has released a draft document for consultation of the well-used Guidance Document for Clinical Trial Sponsors - Clinical Trial Applications.

Some updates that have been made include:

• Harmonizing Module 1 with the newly proposed Common Technical Document (CTD) format (please refer to the draft consultation document entitled 'Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format' posted on the Health Canada website);
• Outlining application requirements with respect to comparative bioavailability studies for pharmaceuticals;
• Providing additional guidance on clinical and quality amendments versus notifications;
• Adding filing requirements for the importation of clinical trial drugs;
• Elaborating on adverse drug reaction (ADR) reporting criteria and;
• Changing the policy on the 7-day administrative review target.

The document was subject to a 90-day comment period in which Health Canada was open to receiving feedback during this period. The Guidance is in the process of being amended as necessary and a final version of this document will be released by Health Canada in due course.

You can request a copy of the draft guidance document from Health Canada by sending an e-mail to publications@hc-sc.gc.ca with the subject line: HPFB Draft Guidance Document: Guidance Document for Clinical Trial Sponsors - Clinical Trial Applications or click here to download the PDF.

MEMBER PROFILE

In this edition, we introduce you to Carolyn Kruse, a seasoned Regulatory leader and President of Kruse Consulting Group, Inc. Carolyn's organization has multiple locations in the US and UK and you can reach her by e-mail: krusecnslt@aol.com or cell phone: +1 802 999 5044.

Please share your experience and areas of expertise

I have 36 years of experience in the pharmaceutical industry (CV available on request) including medicinal chemistry research, US and EU regulatory affairs for both regulatory strategy and documentation preparation as well as interactions with US and EU regulatory authorities.

Where does your job take you?

England, France, Philadelphia, Princeton, San Diego, San Francisco, Boston and Cambridge Massachusetts

What do you like most your job?

The process of drug development and registration remains fascinating after many years in the business. The opportunity to work on projects for different indications with over 100 companies has been fantastic as has been the opportunity to work with incredibly interesting, smart, focused and dedicated people.

LEADERSHIP CORNER

In each issue of the UPDATE, we ask seasoned regulatory leaders to share their views on the Regulatory profession. In this issue, Nancy Smerkanich, Executive Vice President, Global Regulatory Affairs at Octagon Research Solutions, Inc., responds to our question:

What is the most important attribute that you view as critical to success in a Regulatory career?

The Regulatory profession is complex and dynamic. And because of those two attributes, it requires leaders who are knowledgeable, flexible and most importantly, good communicators. In a typical day, you must communicate across many functional areas and you must be knowledgeable and build credibility throughout these interactions. Whether you are interacting with internal product development teams or agency staff, you must be able to articulate your position and leave very little to interpretation.

Communications occur in a variety of forms – emails, phone calls, video meetings, etc. It is important for Regulatory professionals to understand the strengths and weaknesses of these various mediums and use them appropriately. Clear, unambiguous communication is the basis for strong relationships and those relationships are foundational to a successful career in Regulatory. Be aware of your communication style and how it translates across various cultures, mediums and scenarios... it's your job.

TOPRA NORTH AMERICA ACTIVITIES

The North American Leadership Team is planning networking and educational programs for the coming year. We have successfully conducted the Essentials of European Regulatory Affairs course in several cities across North America and will be announcing the course schedule and locations shortly.

As Regulatory professionals, it is important that we keep current on industry trends, maintain our professional skills and leverage our networks to be effective at our jobs. Active participation in TOPRA supports all three of these objectives. Please consider participating in any of the following activities:

• Planning and coordinating regional networking events
• Presenting your experiences and perspectives on key industry topics and trends
• Contributing to our various publications (UPDATE, In Touch and Regulatory Rapporteur
• Attending TOPRA educational course and networking events

To get more involved in TOPRA in North America, you can contact the TOPRA office at topra@topra.org or Monique Garrett, Chair of the TOPRA North America Leadership Team at mgarrett@ocatgonresearch.com.

TOPRA NORTH AMERICA LEADERSHIP TEAM

*Two of our members have received TOPRA's Distinguished Service Award recognizing their ongoing support and exceptional efforts in supporting the goals of TOPRA.

• Lynda Wight (Executive Director; TOPRA Head Office)
• Monique Garrett (NALT Chair)
• *Carlos Langezaal (former Chair, member at large)
• Gillian Ivers-Read (Membership, Business Ops)
• Chris Griffett (Membership)
• Malcolm Lloyd-Smith (West Coast Representative)
• *Patricia Duchene (Publications & Publicity Representative)
• Aman Khera (Canada Representative)
• Patricia Anderson (Canada Representative)
• Nancy Chew (North Carolina Representative)
• Alix Alderman (Midwest Representative)
• Roland Cooke (Device Representative)
• Susan Yule (West Coast Representative)
• Sara Snow (Massachusetts Representative)

IMPORTANT PROFESSIONAL RESOURCES

TOPRA Special Interest Networks (SPIN Groups) provide topic specific networking and discussion forums for various industry sectors. To participate in a SPIN group or learn more about the specific topics, visit our website at www.topra.org/spin. Current SPIN groups include: Biotechnology, CMC, eRA, Medical Technologies, Veterinary, Pharmacovigilance, Regulatory Intelligence, Japan and Clinical Trials.

TOPRA Online Basics Course is now available. To learn more about this highly effective training mechanism, visit our website at www.topra.org/onlinebasics.