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Become a “Regulatory Tactician”: Integrating a Regulatory Strategy

Posted on July 23 2014 | Author: Mary Dimou

Whether a start-up or a high-profile brand, regulatory considerations often fall short to the glamour of product development, packaging, and marketing techniques. Regardless of the industry, these considerations are often deferred to the end of projects, potentially leading to compromised standards, which in severe cases, may lead to monetary penalties.

Entrepreneurs are frequently required to adopt a ‘jack-of-all-trades’ persona, ultimately increasing their susceptibility of overlooking certain critical regulatory requirements. Implementing a strategic regulatory plan can save entrepreneurs’ money and time, facilitate the integration of short-term tactical decision points, and enhance communication with their business team.

Elements of a Regulatory Strategy for Entrepreneurs

A strategic regulatory plan can transform the productivity of a business by simply aligning regulatory considerations with business objectives from the beginning to the end of a project. From the Food and Natural Health Product regulatory perspective, irrespective of whether you are releasing your first or tenth product into the market, reviewing regulatory requirements is essential.

The regulatory affairs’ domain is constantly in flux and a regulatory strategy should be considered a “living document” that can be referenced at every NO/GO decision point of your process from initial prototype to advertising strategy. Defining this process as a “living document” suggests foreseeing deviations to your regulatory strategy regularly and adopting a pragmatic approach to dealing with them.

At various stages of the project, entrepreneurs will encounter both internal and external factors that may alter the regulatory strategy including (but not limited to):

  • Regulations evolving – changes in guidelines, flux of regulatory authorities and standards, consideration of new requirements and legislations available versus those projected
  • Competitive products on the market – viewing the competitive landscape, analyzing the potential players and their location, new intelligence of similar products, recent patents on the market, defining your market position
  • Product development - changes in target label or markets, applying for food safety certifications (Halal, Kosher, Organic, Gluten-Free and GMO-Free) that are most effective in the market and changing manufacturing and distribution practices accordingly
  • Exportation potential – considering international requirements for releasing your product, considering the compliance of particular ingredients – their uses and approval status, updating claims, relevance of certain certifications

Despite these variables, it is imperative to maintain focus on your end goal – using regulations as the catalyst for developing the synergy between clinical, product quality, and business elements.

How You Can Start Developing a Regulatory Strategy

More often than not, entrepreneurs are not aware of the serious time constraint necessary for following the regulatory framework nor the complexity involved in this process. The number of forms, length of applications, and allocation of own time learning regulatory processes can be reduced through an integrated regulatory overlay. This technique will also assist in identifying issues at an early-stage and reduce your workload in the future. Although an expense, connecting with appropriate regulatory consultants throughout the project timeline can also help guide your application with minimal errors and expedite the process of your product launch. Outreaching to pre-market approval and post-market surveillance legislation experts from governmental bodies including Health Canada and the Canadian Food Inspection Agency are also valuable tools in your regulatory strategy and their guidance documents should be visited regularly throughout your process.

Mary Dimou
Bioenterprise Intern
M.Sc. Candidate, University of Guelph

References:
Health Canada
CFIA

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Conferences a plenty!

Posted on July 09 2014 | Author: Jennifer Kalanda

Small business owners are so busy, so the thought of taking a few days away from the office to participate in a conference, trade show or convention can seem like a low priority.  But it’s important to consider all the benefits of getting out there, getting to know your industry and even finding new ways to grow your business.  The trick to ensuring your experience is a prosperous one comes down to finding the right events!

With the list of conferences growing each year, the decision to attend one can require its own due diligence process.  Attending the right conferences can be an important element to the success, expansion or survival of your business.  But where do you even start?

First, determine your goals.
At the end of the day, what do you need to accomplish by attending an event of interest?

Make a short list.
Consider compiling a succinct list of top contenders.  If geography and finances are big factors then this won’t be a long list to put together.  However, don’t be to quick to dismiss an event just because it’s on the other side of the country.  If it meets all the criteria it could be worth your time and investment to attend. 

If you need help determining which conferences should be at the top of your list, try reaching out to your network.  See who has attended what conference, where and why.  Sometimes collecting someone else’s first hand experience can help differentiate a good conference from a bad one. 

Who will be attending?
What kind of people do you need to connect with and are they at the conference?  The demographic of the delegates will often be the deciding factor.  Sometimes sending a quick email to the conference organizers can help answer this question.  While conference organizers won’t go around giving out names and phone numbers, they are usually open to sharing their demographic charts or even a list of the position titles and company names of who attended the previous year.  A list rich in senior titles and quality firms is a good sign!

Another way to determine the conference audience is to look at the list of sponsors.  Sponsors spend even more time evaluating whether a conference is a good fit.  If you are familiar with the sponsors, then you should be able to wrap your head around why they have chosen to be a sponsor.

Are the topics relevant to your sector or business?
Don’t overlook the agenda.  If you are going to make time to attend a conference, try to make sure you will be able to learn a thing or two!  Conferences host panels and keynote speakers who discuss industry trends, challenges or hurdles and forward thinking ideas.  

Also be sure to consider how much time the organizers have allotted to networking.   Making a couple of strong contacts or leads can make any conference worth it, but you want to make sure there is enough time provided to do so.

And of course, how far do you have to go?
Travelling, flights and accommodations all add up and can be a pretty big expense, but if the conference is a must, find ways to make the cost of travel more justifiable.  Review your network and see who is near by, or even attending the conference themselves.  You can take advantage of the travel by setting up meetings with your contacts or even get in front of new ones.  Get into town a day early booked with meetings; if nothing else that day alone should merit your time away.

The decision on what conference to attend can be a bit of work, but the right conference will likely be worth it!

Happy conferencing!

Jennifer Kalanda
Events Coordinator






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