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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA PAC iAM Workshop

Science- and Risk-Based Approaches to Technical Change Management
Sep 13 - Sep 14, 2017 |
Sep 14, 2017 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Workshop
  • Western Hemisphere Events
Exhibition: September 13-14
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Today the global management of post-approval changes (PACs) and the required regulatory reporting burden continues to grow in complexity and challenges the pharmaceutical manufacturing industry to continuously improve and innovate efficiently. The PDA PAC iAM Workshop will provide overviews and insights on how industry and regulatory authorities are working together to support post approval changes through development of a new guidance, ICH Q12.

Learn how good change management as part of an effective pharmaceutical quality system can be measured and contribute to reducing regulatory burden. Participate in breakout sessions to discuss and experience practical tools for implementation of ICH Q12 concepts, including leveraging established conditions and development of change management protocols. Interact and share your ideas with PDA’s PAC iAM Task Force members who are working to support these initiatives. Don’t miss this opportunity to learn from experts involved in development of ICH Q12 and how implementation of these concepts and tools can optimize global post-approval change management at your company!

Wednesday, September 13, 2017

11:30 a.m. – 5:30 p.m.
Registration Open

1:00 p.m. – 1:15 p.m.
Welcome and Opening Remarks
Ursula Busse, PhD, MBA, Quality Intelligence, External Relations, Novartis and Co-Chair, 2017 PDA PAC iAM Workshop
Lisa M. Skeens, PhD, Vice President, Global Regulatory Affairs, Pfizer, Inc. and Co-Chair, 2017 PDA PAC iAM Workshop

1:15 p.m. – 2:45 p.m.
P1: Opening Plenary: Why is a Global Dialog Important? Why Now?
Moderator: Emma Ramnarine, Senior Director, Head Global Biologics QC Network, Genentech/Roche

Session Description: Post-approval changes have been routine in the commercial life of a product. However, the complexity created by opposing forces of companies having to operate in increasingly global markets while health authorities continue to evolve their national regulations, has increased, resulting in higher barriers for innovation, continuous improvement and raising the risk of drug shortages. This has elevated the need and urgency of finding global solutions to reduce the complexity and improve speed of post approval change implementation. This opening plenary session will provide you the case for change, why a global dialog is essential, what changes are needed and some global solutions that are being discussed by industry and regulators.

1:15 p.m.-1:35 p.m.
Innovation – Hurdle Race or Fast Track?
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur

1:35 p.m. – 1:55 p.m.
ICH Q12 - Solutions for Addressing Complexity and Speed of PACs
Regulatory Representative Invited

1:55 p.m. – 2:15 p.m.
International Activities Related to Post Approval Changes: Opportunities and Challenges
Isabelle Colmagne-Poulard, Senior Director, Regulatory CMC Strategic & Technical Advisor, Global Regulatory Affairs & Quality Assurance, Merck, and member of IFPMA RPTS

2:15 p.m. – 2:45 p.m.
Questions and Answers/Discussion

2:30 p.m. – 6:00 p.m. 
Exhibit Area Open

2:45 p.m. – 3:15 p.m.
Refreshment Break in Exhibit Area

3:15 p.m.-4:45 p.m.
P2: Established Conditions and Change Categorization
Moderator: Lisa M. Skeens, PhD, Vice President, Global Regulatory Affairs, Pfizer, Inc.

Session Description: An important concept to the new regulatory paradigm for post approval changes is proactively defining the Established Conditions for a regulatory dossier.  In this session, experts from FDA and industry involved in ICH Q12 guidance development will explain Established Conditions, and the following categorization of post approval changes in the new paradigm.  The opportunities for leveraging this concept globally to drive efficiency and effectiveness for both regulators and the pharmaceutical industry will be discussed.

3:15 p.m. – 3:45 p.m.
Frank Montgomery, Global Head, Regulatory CMC, AstraZeneca

3:45 p.m. – 4:15 p.m.
A Regulator’s View on the Value of Dossier Established Conditions
Regulatory Representative Invited

4:15 p.m. – 4:45 p.m.
Questions and Answers/Discussion

4:45 p.m. - 6:00 p.m.
Networking Reception in Exhibit Area

Thursday, September 14, 2017

7:15 a.m. – 3:30 p.m.
Registration Open

7:30 a.m. – 8:30 a.m.
Continental Breakfast

8:30 a.m. – 10:00 a.m.
P3: Elements of Lifecycle Management Strategy
Moderator: Mihaela Carmen Simianu, PhD, Director of Regulatory Compliance, Pharmtech Associates

Session Description: A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry and regulatory authorities. ICH Q12 is introducing Product Specific Lifecycle Management (PSLCM) Strategy document as a tool, serving as a central repository for the Established Conditions and the associated reporting category when making changes to Established Conditions. The document may proactively identify some of the anticipated post-approval changes to promote transparency between the firm and regulatory authorities. During this session we will dive deeper into the technical elements of the Life Cycle Management, the channels and value of proactive communication of LCM Strategy with regulators/assessors.

8:30 a.m. – 9:00 a.m.
Product Specific Life Cycle Management Strategy Document Application/Case Study for Biologics
Emma Ramnarine, Senior Director, Head Global Biologics QC Network, Genentech/Roche

9:00 a.m. – 9:30 a.m.
Expectations and Incentives: LCM Strategy and knowledge sharing with Regulators: FDA
Regulatory Representative Invited

9:30 a.m. – 10:00 a.m.
Panel Discussion
Andrew C. Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk
Regulatory Representative Invited
Emma Ramnarine, Senior Director, Head Global Biologics QC Network, Genentech/Roche

9:45 a.m. – 4:00 p.m.
Exhibit Area Open

10:00 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area

10:30 a.m. – 12:15 p.m.
Concurrent Breakouts

Session 1: 10:30 a.m. – 11:15 a.m. | Session 2: 11:30 a.m. – 12:15 p.m.

Breakout A: Established Conditions & Change Categorization

Facilitator: Gopi Vudathala, PhD, Head, Quality Advocacy Liaison, GSK Vaccines

Scribe: Suzanne Kiani, Senior Director, Regulatory Science, Biologics, Global Regulatory Affairs, Mylan Inc.

Discussion Leaders: Sally L. Anliker, Regulatory Scientist, Eli Lilly and Company

Session Description: An efficient and effective process to manage post approval changes encourages product and manufacturing innovation throughout a product’s life cycle. This session will provide practical tools and examples on how to leverage the concepts in ICH Q12 including established conditions and change categorization. It will look at how established conditions are identified and applied, leveraging a risk-based change categorization decision model. It will also further explore how product/process knowledge can be leveraged, and discuss ways to minimize the burden of reporting post approval changes. The hands on session will provide workshop participants an opportunity to dive deeper in industry’s understanding and application of established conditions and change categorization, and share their perspectives on how it can further optimize the change management process for both industry and regulators.

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Breakout B: Change Management and the Pharmaceutical Quality System

Facilitator: Ursula Busse, PhD, MBA, Quality Intelligence, External Relations, Novartis

Scribe: Marazban Sarkari, Director, Pharmaceutical Operations R&D, Teva Pharmaceutical Industries Ltd Israel

Discussion Leaders: Marcello Colao, Director, Quality Regulatory Compliance, GlaxoSmithKline Vaccines

Session Description: When changes are made during the commercial life of a product, robust implementation of the principles described in ICH Q10 (an effective PQS, product and process understanding and use of quality risk management) ensure that product quality, patient safety and adequate supply to patients are safeguarded. In this session, the different elements that contribute to effective change management as well as their inter-relationship will be explored. In role plays and using case studies, participants will be able to perform the change management steps and determine key elements for effective change management. They will experience how to leverage an effective PQS in conjunction with knowledge and quality risk management to test to which extent changes can be managed without review and approval by the regulator. Challenges and opportunities of the enhanced approach as proposed by ICH Q10, Annex 1, will be discussed.

12:15 p.m. – 1:15 p.m.
Networking Luncheon

1:15 p.m. – 2:15 p.m.
Small Group Discussion

Session Description: Performing changes to commercial products and associated processes is essential for lifecycle management of a product. How can post approval change protocols be prepared in the future to align and take advantage of ICH Q10 and ICH Q12 concepts? In this session participants can observe, comment and engage in a dialog on approach, structure and content of Post Approval Change Management Protocols (PACMP) for one of the following case studies: a) Analytical Method Change (Biologics) b) Raw Material Change (Oral Drug Product) c) Manufacturing Process Change to Isolator (Injectable). In addition to providing the first few examples of specific PACMPs in the upcoming PDA Technical Report, PDA will also establish a library of examples for specific global PACMPs that can be leveraged as templates. We will also collect your input on future examples to be used as case studies.

Group 1: Analytical Method Change (biologic)
Alleviating Regulatory Burden of Post-Approval Method Change
Moderator: Kassidy Polk Good (tentative), Manager, Global Regulatory Affairs CMC Biologics, Mylan

Group 2: Material Change (oral drug product)
Raising Requirements in One Country to Achieve Harmonization Across Many?
Moderator: Kara Follmann, Senior Director, Global Established Products, Regulatory Affairs Brand CMC, Pfizer, Inc.

Group 3: Manufacturing Process Change to Isolator (injectable)
Will the PACMP Reduce Regulatory Filing Requirements and Alleviate Supply Chain Concerns?
Moderator: Karolyn Gale, Manager Regulatory Affairs at Emergent BioSolutions, Emergent BioSolutions

2:15 p.m. – 2:45 p.m.
Refreshment Break and Poster Presentations in Exhibit Area

2:45 p.m. – 5:00 p.m.
P4: Closing Plenary: Broader Perspectives on Regulatory Convergence
Moderator: Ursula Busse, PhD, MBA, Quality Intelligence, External Relations, Novartis

Session Description: After an overview of key messages collected from the breakout sessions, a panel discussion will bring together thought leaders from the ICH Q12 Expert Working Group, the WHO, the international trade association IFPMA, PDA and manufacturing innovation. Participants will hear first-hand from those involved how international initiatives in the post-approval space will foster regulatory convergence of PAC regulations, encourage adoption of shared principles in line with ICH Q12 and facilitate manufacturing innovation globally. This session intends to provide insights into global solutions to PAC regulatory complexity and leave the audience with an outlook into a bright future for manufacturing innovation.

2:45 p.m. – 3:30 p.m.
Breakout Debrief

3:30 p.m. – 4:30 p.m.
Panel Discussion
Regulatory Representative Invited
Regulatory Representative Invited
Susanne Martz, PhD, Senior Vice President of Quality Vaccines, GlaxoSmithKline and Member of IFPMA Vaccines Heads of Quality Group
Morten Munk, Global Technology Partner, NNE
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
WHO Representative Invited

4:30 p.m. – 5:00 p.m.
Questions and Answers/Discussion

5:00 p.m.
Closing Remarks and Adjournment
Lisa M. Skeens, PhD, Vice President, Global Regulatory Affairs, Pfizer, Inc. and Co-Chair, 2017 PDA PAC iAM Workshop

Conference and Workshop Registration | September 11-14, 2017

Member

Before June 30, 2017
$3,740

June 30 - August 1, 2017
$4,190

After August 1, 2017
$4,640

Non-member

Before June 30, 2017
$4,219

June 30 - August 1, 2017
$4,669

After August 1, 2017
$5,119


Workshop Registration | September 13-14, 2017

Member

On or Before Aug. 1, 2017
$1,495

After Aug. 1, 2017
$1,695

Non-member

On or Before Aug. 1, 2017
$1,695

After Aug. 1, 2017
$1,895


Government/Health Authority/Academic

Member

On or Before Aug. 1, 2017
$700

After Aug. 1, 2017
$700

Non-member*

On or Before Aug. 1, 2017
$800

After Aug. 1, 2017
$800


Student

Member

On or Before Aug. 1, 2017
$280

After Aug. 1, 2017
$280

Non-member*

On or Before Aug. 1, 2017
$310

After Aug. 1, 2017
$310

All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this Workshop.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by July 13, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If your written request in received on or before July 13, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Workshop materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials onsite. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA events.

Renaissance Washington, DC Downtown Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000

Rate: Single: $315.00, plus applicable taxes (14.5%).

Cut Off Date: Friday, August 11, 2017 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2017 PDA/FDA Joint Regulatory Conference, and the 2017 PAC iAM Workshop to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Metro
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train
Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Driving
Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self-Parking
$45 / Daily Valet Parking

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