health canada

Take away 10 practical solutions to better tackle:

1. Radical Modernization: Ensure faster compliance with Bill C-17/

Vanessa’s Law

2. Successful Submissions: Expedite the approval process

3. Risk Mitigation: Maximize the safety of your drugs

4. Financial Stability: Protect your finances from catastrophic collapse

5. Labelling Transparency: Ensure clarity for drug users

6. SEB Compliance: Align your SEB development with recent regulations

7. Quality by Design: Embed robust quality protocols and enhance GMP

8. Market Access: Learn how pricing and reimbursement are affected

9. International Cooperation: Leverage global regulatory harmonization

10. Industry Leadership: Secure your high standing in Canadian pharma

Attain crucial insights from 10 regulatory affairs experts:1. Health Canada

2. Roche

3. Sanofi

4. AbbVie Corporation

5. Janssen-Johnson & Johnson

6. Apotex

7. Valeant Pharmaceuticals

8. Hospira

9. Rx&D

10. JAMP Pharma

Hear from these leaders:

Monday June 22nd - Tuesday June 23rd, 2015Sheraton Centre Toronto

Agnes Klein,Director, Centre for Evaluation of

Radiopharmaceuticals and Biotherapeutics,

Biologics and Genetic Therapies Directorate, Health Canada

Catherine Lau,VP, Regulatory Affairs and Quality

Management,

Janssen Pharmaceutical Companies of Johnson & Johnson

Elisabeth Kovacs,Chief Scientific Officer, Chemistry and

Analytical Sciences,

Apotex

Loretta Del Bosco,Director, Regulatory Affairs & Quality

Assurance,

AbbVie Corporation

Lisa ChartrandDirector, Regulatory Affairs and Quality

Management,

Hoffman-La Roche Limited

Partners:Bronze Sponsor:Silver Sponsor:

KEY INSIGHTS FROMHealth Canada

Prepare & get your

QUESTIONSANSWERED!

www.pharmaregulatory.ca

THE TIME IS NOW. Regulatory Policy Has Entered a New Era. Are you Prepared?

Get Clarity on the Biggest Transformation Facing Canadian Pharma in 20 YearsHealth Canada’s regulatory overhaul has left Canadian pharma with urgent questions and fears. Seize this opportunity to modernize your safety and quality procedures. Gather the very latest intelligence on your key questions about Bill C-17/Vanessa’s Law from Health Canada and leading pharmaceutical companies.

Grapple with the ambiguities inherent in the new legislation and establish next steps to ensure your compliance. This interactive forum is your one-stop event for regulatory affairs intelligence.

Overcome obstacles to regulatory approval, mitigate safety risks, and avoid crippling financial penalties.

Your first step to source expertise unavailable elsewhere – THIS CONFERENCE!

Take away 10 practical solutions to better tackle:

1. Radical Modernization: Ensure faster compliance with Bill C-17/Vanessa’s Law2. Successful Submissions: Expedite the approval process3. Risk Mitigation: Maximize the safety of your drugs both pre- and post- marketing4. Financial Stability: Protect your finances from catastrophic collapse5. Labelling Transparency: Ensure clarity for drug users6. SEB Compliance: Align your SEB development with recent regulations7. Quality by Design: Embed robust quality protocols and enhance GMP 8. Market Access: Learn how pricing and reimbursement are affected9. International Cooperation: Leverage global regulatory harmonization10. Industry Leadership: Secure your high standing in Canadian pharma

Our Five Conference Differentiators:

1. In-depth exploration of Bill C-17/Vanessa’s Law and what it means for you2. Representation from Health Canada3. Exclusive speaker line-up featuring big, mid, and small pharma4. Replicable strategies for immediate implementation within your organization5. Interactive discussions built into every session

Don’t Miss This Invaluable Opportunity – Register Today!

Register now for Canada’s new and exclusive pharma regulatory affairs summit. Learn from the experiences of our elite

speakers. Call 1-866-298-9343 or email [email protected] today.

1. Health Canada2. Roche3. Sanofi4. AbbVie Corporation5. Janssen-Johnson & Johnson

6. Apotex7. Valeant Pharmaceuticals8. Hospira9. Rx&D10. JAMP Pharma

Attain crucial insights from 10 regulatory affairs experts:

Send 3 delegates and the 4th delegate attends for FREE!

Attend for

1-866-298-9343 | [email protected]

Be Prepared for a Historical Turning Point Impacting Canadian PharmaPharmaceutical Companies VP/Director/Manager/Associate/Officer/Advisor: Regulatory

Affairs, Compliance, Drug Safety, Scientific Affairs, Quality

Assurance, Government Affairs

• Align your organizational processes with the current

regulatory landscape

• Hear directly from Health Canada about recent changes to

guidance documents

• Manage and document your regulatory procedures

effectively and productively

Contract Manufacturing and Research OrganizationsVP/Director/Manager/Associate/Officer/Advisor: Regulatory

Affairs, Compliance, Drug Safety, Scientific Affairs, Quality

Assurance

• Gather regulatory intelligence from Health Canada and

industry experts

• Meet the same regulatory standards that govern

pharmaceutical establishments

• Establish robust compliance strategies and consolidate

your leadership as a CMO/CRO

Consultants, Lawyers, Solution Providers: Document Management Systems, Software, Regulatory Information ManagementCEO | Consultant | Director/VP: Business Development,

Marketing, Sales

• Showcase your leadership and intelligence to

pharmaceutical companies

• Forge partnerships with key decision-makers and industry

leaders

• Connect with a receptive audience seeking your timely

expertise and solutions

Ensure Your Leadership with a Customized Sponsorship/Exhibit Package

Showcase your company’s intelligence and expertise to a receptive audience. Ensure your presence is known in the industry. Select sponsorship packages are still available. To learn more, contact Simon Wright at 1-866-298-9343 x275, or email [email protected].

Don’t take our word for itHear what your peers have to say

“ Very comprehensive. A solid overview of the current state of market access in Canada and globally.”… Greg Buie, Brand Director, Novartis

“ Great selection of topcs and speakers. Timing and presentation counts well planned. Food was up to par.”… Roman Z., Health Economics and Pricing Association and Takeda Canada

“ The market access summit is a superb networking opportunity and a strategic MA event.”… G. Giroux, Director, Market Access Pendo Pharm

“ The focus is aligned with where the field and industry are heading. Very nice to see physicians and patients included.”… Craig Wakeford, Manager, Sanofi Canada

“ Very informative and broad aspects of market access covered.”… Apoorva Kelkar, Market Access Associate, Wyatt Health Management

“ Excellent conference to network with colleagues across the industry.”… Kristina Gentes, Manager, Reimbursement and Med. Affairs, Servier Canada Inc.

“ All sessions have been informative. I liked the variety in the topics. For me, therapeutic sessions were most helpful.”… Natalie B., McKesson

“ Excellent / relevant topics. Good breadth of material. Liked the varied formats (panel vs. speaker)”… H. Jibry, Pharmaceutical Portfolio Manager, Shoppers Drug Mart

“ A good crash course on the market access landscape. It has the impact of providing good networking connections but also a broad survey of the regulatory landscape.”… Aaron Levo, Canadian Cancer Society


7:30 AM Registration and Continental Breakfast

8:15 AM Opening Comments from the Chair

Sara ZborovskiPartner (Toronto)

DLA Piper (Canada) LLP

8:30 AM Regulatory Updates

Implementing Health Canada’s New Authorities: An Indus-try PerspectiveKnow the new expectations for pharma companies following the enactment of Bill C-17/Vanessa’s Law. Learn what is at stake for your company and what you need to do to avoid significant finan-cial penalties. Source regulatory guidelines and best practices to:• Learn how the new authorities might best be implemented • Comply with post-market requirements and the evolving

transparency framework • Work with Health Canada to put these new rules into action

Take concrete steps to apply the changes demanded by Bill C-17/Vanessa’s Law in your organization.

Keith McIntosh,Executive Director, Scientific and Regulatory Affairs,

Canada’s Research-Based Pharmaceutical Companies (Rx&D)

9:30 AM Bill C-17/Vanessa’s Law

Overcoming Your Regulatory Hurdles to Achieve ComplianceImplementation of Bill C-17/Vanessa’s Law provides the pharmaceutical industry with a great opportunity to fine tune its tools and procedures to ensure maximal drug safety. Strengthen the safety oversight of your therapeutic products over their entire life cycle in this new regulatory era. Discussion will focus on:• Assessing the scope of the new power• Increasing transparency in terms of risk communication• Ensuring timely communication of product safety information

and regulatory decisions

Maintain the integrity of your manufacturing process amidst new regulatory frameworks.

Catherine Lau, VP, Regulatory Affairs and Quality Management,

Janssen Pharmaceutical Companies of Johnson & Johnson

10:15 AM Mid-morning Networking Break

10:45 AM International Harmonization

Streamlining Regulatory Procedures Through Canada-US Regulatory AlignmentHarmonization efforts between Health Canada and the FDA have been initiated to facilitate the operations of both regulators. Better comprehend the role of Canada’s Regulatory Cooperation Council in enabling this collaboration. Identify the implications of this initiative for your organization. Here the latest news on:• Simplifying the exchange of information between regulatory

bodies and trading partners through electronic submissions• Increasing mutual reliance on GMP Inspections• Emulating the US transparent regulatory model

Leverage regulatory cooperation initiatives to facilitate your submissions process.

Loretta Del Bosco,Director, Regulatory Affairs, Quality Assurance, Operations,

AbbVie Corporation

Alice TsengPartner

Blake, Cassels & Graydon LLP

12:15 PM Networking Luncheon

11:30 AM Interactive Discussion

Get Answers to Your Most Pressing Questions About Bill C-17/Vanessa’s LawThe recent regulatory changes have evoked a great level of uncertainty. In this interactive session, you will take part in group discussion and get answers to your key questions. Get clarification on points such as:• What are the concrete expectations?• How does one interpret the guidance documents?• How will changes be interpreted and enforced by inspectors

and auditors?• How far does Health Canada intend to go?

Incorporate your own concerns into the conversation!

DAY ONE Monday June 22nd

About This Conference:The Summit on New Health Canada Regulatory Reforms is designed to bring together senior professionals from pharmaceutical companies working in regulatory affairs. This forum will provide delegates with actionable intelligence to stay compliant amidst radical regulatory modernization.

1-866-298-9343 | [email protected]

1:30 PM Drug Submissions

Best Practices for the Success of Your Submissions ProcessFrom simple generic drugs to complex generics requiring clinical efficacy studies, it is becoming increasingly important to support drug submissions with strong scientific evidence of bio-equivalence and therapeutic equivalence. Demystify the complex generic drug approval process for your new and abbreviated submissions. Gather key insights on Health Canada’s recent initiatives surrounding:• Harmonizing the global drug approval process• Meeting API GMP guidelines• Establishing a science-driven approval process

Ensure the approval of your drugs while adhering to current regulatory guidelines.

3:30 PM Panel: Post-Market Risk Management Planning

Managing Product Safety Compliance beyond the Development PhaseMonitor the safety and efficacy of your products while on the market and make the necessary changes in your manufacturing and labelling practices to respond to emerging risks. Refine your RMP to improve long-term surveillance of your drugs. Source strategies to:• Develop post-approval risk management systems that meet

regulatory requirements• Monitor implementation and assess the effectiveness of your

post-approval RMP• Implement global risk management plans within the Canadian

regulatory framework

Meet your post-marketing obligations for all your therapeutic products.

Lisa Chartrand,Director, Regulatory Affairs and Quality Management,

Hoffmann-La Roche Limited

Diana Basmadjian, Associate Director, Pharmacovigilance and Medical Information,

Sanofi Canada

4:45 PM Conference Adjourns to Day Two

5:00 PM Evening Social Activities

Network with industry leaders while enjoying some of the best Toronto has to offer. Start by joining fellow delegates and speakers for complimentary appetizers.

3:00 PM Mid-afternoon Networking Break

A. Kelly Gill,Partner,

Gowling Lafleur Henderson LLP

Anita Nador,Partner, Patent Agent, Trademark Agent,

Gowling Lafleur Henderson LLP

2:15 PM Look-alike Sound-alike Drugs

Explore the New Requirements for Confusing Drug NamesDecipher the new guidance documents and learn what you have to do to stay compliant. Conduct more extensive consultations in order to base your products on solid evidence. Update your procedures in order to:• Minimize confusion• Reduce medication errors• Eliminate risk to the consumer

Get clarification on recent regulatory updates and revolutionize your LASA drug protocols accordingly.


DAY TWO Tuesday June 23rd

9:00 AM Registration and Continental Breakfast

9:30 AM Opening Comments from the Chair

Sara ZborovskiPartner (Toronto)

DLA Piper (Canada) LLP

9:45 AM Quality by Design

Applying Lifecycle Management Concepts to Analytical Procedures for Continual ImprovementResults generated using analytical procedures provide the basis for key decisions regarding compliance with regulatory, compen-dial, and manufacturing limits. Adopt a lifecycle approach to the development, qualification and routine commercial use of analyti-cal procedures. Further ensure that your analytical results support these decisions with a high level of confidence. Gather insights to:• Identify the application of ICH Q 8, 9, and 10 to analytical procedures• Enhance product understanding and process control• Ensure that your analytical procedures meet predetermined

performance requirements

Base your drug development and risk management initiatives on sound scientific evidence.

Elisabeth Kovacs,Chief Scientific Officer, Chemistry and Analytical Sciences,

Apotex

10:30 AM Vaccine Shortages in MRA Countries

Opportunities for Cooperation Between MRA Manufacturers and Regulatory Authority Lot ReleaseOver the last 10 years there has been supply shortage for vaccines in Mutual Recognition Agreement countries. Reasons include long cycle times to release, requirements for national regulatory authority release, and low flexibility when one or more batch fails. Establish your next steps towards:• Meeting the increasing international supply demands• Ensuring acceptance of lot release certificates from another

regulatory authority in the same MRA region• Expanding MRA to address inter-jurisdictional requirements

beyond GMP

Unleash the potential of regulatory harmonization for your human biologics.

Martin Los,Director, Product Quality & Quality Operations Planning,

Sanofi Pasteur

11:15 AM Mid-morning Networking Break

11:45 AM Orphan Drugs

Regulatory Intelligence on Drug Development for Rare DiseasesObtain clarification on Health Canada’s framework for the designation, authorization, and monitoring of orphan drugs. Leverage international cooperation to facilitate your own drug development efforts. Gather intelligence to:• Identify exclusivity and other incentives for orphan drug

development• Better comprehend the existing legislation• Align your efforts with international initiatives

Assess your company’s capabilities against the current regulatory landscape.

Agnes Klein,Director, Centre for Evaluation of Radiopharmaceuticals and

Biotherapeutics,


12:30 PM Networking Luncheon

1:45 PM Subsequent Entry Biologics

Align Your SEB Development Processes With Current RegulationsNew guidelines for SEBs with demonstrated similarity to previously approved biologic drugs. Gather insights from Health Canada on what requirements you must meet at this time. Take away strategies to:• Cultivate a spirit of innovation while complying with rigorous

expectations• Adhere to New Drug Submission regulations• Meet the same standards as other biologics

Recognize your opportunities and the demands surrounding SEB development in Canada.

Agnes Klein,Director, Centre for Evaluation of Radiopharmaceuticals and

Biotherapeutics,


2:30 PM Global Development of Biosimilars

Best Practices for Meeting Quality / Safety Considerations and Reducing RiskGather crucial intelligence for your SEB development process, from the clinical trial to the marketing stage. Ensure your compliance with the scientific standards demanded for SEB submissions and for all therapeutics. Learn how you can:• Conduct a comprehensive comparability study• Develop an RMP that tackle characteristics and threats specific

to SEBs• Adhere to all labelling and post-market requirements

Source compliance strategies from the industry to apply within your own organization.

Eva Essig,VP, Global Regulatory Affairs, Biologics

Hospira

3:15 PM Interface Between Regulatory Policy and Market Access

Implications for Market Access, Reimbursement, and InnovationHealth Canada regulations may impact market access efforts for innovative products and those of your competitors. Hear how the growing interface between Health Canada’s regulatory role and CADTH and provincial market access reviews may affect how your products reach patients. Gather important insights on:• Identifying how health technology assessment and

reimbursement are affected• Modifying your access strategy in accordance with recent

developments• Planning the for greater integration of regulatory and market

access initiatives in the long-term

Ensure that your market access efforts remain unhindered by the new regulatory demands.

Philip Schwab,Senior Manager, Federal Government Relations,

AbbVie Canada

4:00 PM Conference Adjourns

Post-Conference Master Class Workshop

Wednesday June 24th, 2015: 9:00 AM – 12:00 PM

Minimizing Your Liability in a New Regulatory Era of Radical ModernizationWith the amendments to the Food and Drugs Act coming into force, the Canadian pharmaceutical compliance and enforcement landscape has entered a new chapter. With Health Canada’s extensive new investigative and enforcement powers and a substantial increase in the severity of potential penalties for non-compliance, a lot is at stake for the industry. Know what you must do to avoid significant financial loss. Attend this interactive workshop to explore what the passage of Bill C-17/Vanessa’s Law means for your company. Learn what you can to do avoid liability under the Food and Drugs Act. Source expertise to:

1. Assess how you are affected by Health Canada’s new investigative powers, including the power to compel confidential business information

2. Tailor your compliance strategies according to Health Canada’s published approach to compliance and enforcement

3. Avoid the new punishment provisions, including officer and director liability

4. Develop comprehensive strategies and best practices to avoid liability

5. Present a credible “due diligence” defense in the worst case scenario

Take steps to maintain your company’s financial integrity amidst increasingly stringent regulations.

Timothy Squire,Partner,

Fasken Martineau

Book your accommodations at the Sheraton Center Toronto by Monday May 25th, 2015 for an exclusive rate of $229/night by mentioning “Pharma Regulatory Summit by Strategy Institute”, when you call 1-888-627-7175

Sheraton Centre Toronto123 Queen Street West, Toronto, OntarioM5H 2M9, Canada

Direct: +1 (416) 361-1000Reservations: 1-888-627-7175

YOUR VENUE: Sheraton Centre TorontoLocated in the heart of vibrant downtown Toronto, in the financial and entertainment districts, the CAA/AAA four diamonds Sheraton Centre Toronto enjoys an unparalleled location on Queen St. West, directly across from City Hall and Nathan Phillips Square. Maximize your networking opportunities by staying at the same hotel as the conference!


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Admission Policy: Strategy Institute reserves the right to restrict entry to the conference to any individual. Any such person requested to leave the conference site shall do so immediately upon request, whether previously issued a badge permitting entry. There is no refund payable with respect to anyone refused entry. Any information obtained at the conference cannot be relied upon for any particular set of circumstances, cannot be taken as professional advice or opinion. Attendees must consult with the appropriate professional before acting in response to information obtained at the conference. Evening Social Activities: Please drink responsibly. Strategy Institute shall not be liable for any consequential damages and/or personal injuries caused by excessive or irresponsible alcohol consumption.

HOW TO REGISTER:

1-866-298-9343 ext. 200

[email protected]


Strategy Institute401 Richmond St. West. Suite 401Toronto, Ontario M5V 3A5

Registration fee:

The registration fee includes luncheon, receptions, refreshments,

networking breaks, continental breakfast, and original course materials.

Payment is required in advance and can be made by company cheque,

VISA, MasterCard, or American Express. Please make cheques payable

to the Strategy Institute Inc. and write the registrant’s name on the face

of the cheque.

Early Bird special:

Expires on April 3rd and May 10th, 2015. Cannot be used with group discount.

Group Discount:

A Group Discount is offered for this conference (not in combination with

any other offer). To be eligible for the Group Discount, delegates MUST

register at the same time. The total discount per delegate (including

applicable group discounts, etc.) MUST not exceed 25% of the regular

conference cost.

Cancellations:

Cancellations must be received in writing by Monday June 8th, 2015.

Cancellations received by this date will be eligible for a prompt refund less

a $495.00 (plus HST) administration fee. If you register for the program

and do not attend, you are liable for the full registration fee unless you

cancel according to the terms stated above. If you are unable to attend,

delegate substitution is permitted up to, and including, the day of the

conference.

CONFERENCE CODE: 115026

Monday June 22ndTuesday June 23rd, 2015Sheraton Centre Toronto

Early Bird Specials:

SAVE $400: Expires April 3rd ❏

SAVE $200: Expires May 10th ❏

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Disclaimer: Strategy Institute reserves the right to change or adjust the agenda without notice.

Regular Investment: $2,195

Conference + 1 Workshop: $2,590

Workshop Only: $795

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