Webinar on Next Generation of Central Monitor and Monitoring in RBM-Industry Updates


With the inclusion of centralized monitoring in risk based monitoring (RBM) approach; the Central Monitor is emerging as a key and important role in successful implementation of this new monitoring approach. The role of the Central Monitor and function of central monitoring is only just being introduced or is yet to be introduced but we already need to be flexible to adapt to changes. These changes are due to multiple factors.

•  New regulations and guidance
•  2nd and 3rd generation methods
•  2nd generation RBM tools

This will webinar will discuss the impact of these changes on roles and functions.

Date: Tuesday, June 21, 2016

Time: 11:00 AM EST


Andy Lawton
RBA Consultant, Formerly Global Head of Clinical Data Management
at Boehringer Ingelheim

Ashok Ghone, Ph.D.
VP-Global Services, MakroCare, USA

For further details mail us at webinar@makrocare.com


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Webinar on Strategies for Global Labeling Management in Changing Reg Environment


Gerrit-Jan-Nijveldt                                                           Carlos-Langezaal

Gerrit Jan Nijveldt                                                  Carlos Langezaal
Senior Director,                                                       Director,
Regulatory Labeling,                                             Global Regulatory Affairs,
Sanofi                                                                          Eisai, Inc.


This is a significant year as far as rule making for labeling is concerned. Several labeling regulations are anticipated this year.  Designing a Product label that is compliant with the current FDA regulations is complex and time taking. Pharmaceutical companies are constantly managing product-labeling documents such as Package Inserts (PIs), Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). The same information is often duplicated for various product strengths, dosage forms and presentations, resulting in an overwhelming set of labeling records that are difficult to manage and keep synchronized.

If you are part of Regulatory – Labeling team in your company, you should not miss this Webinar. As you are constantly working to coordinate a more robust end-to-end labeling process, and trying to get yourself up to speed on the newest emerging regulations / guidances from FDA and EMA, MakroCare brings you this opportunity to learn about A-Z of Labeling to Global labeling process and practical challenges faced in day-to-day operations from our duo experts Gerrit-Jan Nijveldt, Senior Director, Regulatory Labeling, Sanofi and Carlos Langezaal, PhD, Director, Global Regulatory Affairs, Eisai, Inc. Some of the points being covered are listed below.

Gerrit’s Topic:  “End-to-End Labeling: From Core Labeling Creation to Implementation
•  What is Core Labeling (short version)
•  How to update a CCDS
•  Implementation of core labeling
•  Tracking of implementation why how and what
•  Agency inspection of labeling implementation

Carlos’s Topic:  Eisai’s Global Labeling Practices
•  Who is Eisai Global Labeling and who are the stakeholders
•  Eisai Global Labeling Function
•  Overview of Global Labeling process
•  Practical challenges

Date/ Time: Thursday,May 19th @ 11am EST

Speakers Details:

Gerrit Jan Nijveldt
Gerrit-Jan Nijveldt is currently senior Director, Global Regulatory Affairs Labeling for Sanofi in Bridgewater, NJ. Gerrit and his team are responsible for developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation for the therapeutic area Diabetes and Devices.

Gerrit has an MSc in Medical Biology from University of Utrecht in the Netherlands and started working in pharmaceutical industry in 1991 in the Netherlands and has worked since 1997 in the Global Regulatory Labeling department.

Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Labeling where he teaches in the Quality Assurance and Regulatory Affairs Masters Program.

Carlos Langezaal, PhD
Carlos R. Langezaal, Ph.D., Director, Global Regulatory Affairs, is currently head of the Global Labeling group which is a function in the Global Regulatory Affairs Core Functional Unit at Eisai. The Global Labeling group within Eisai is responsible for a number of tasks including the development, revision, review, and approval of the Company Core Data Sheet and the Country Product Information for all products globally. Previously, he worked at Eisai, Sanofi-Aventis, J&J PRD, Schering-Plough, Core Technologies, Eli Lilly, and Baxter in various therapeutic areas, including oncology, allergy, respiratory and internal medicine. He has more than 20 years of experience in regulatory affairs, having worked in the device, device/drug combination products, CMC and clinical/non-clinical development areas primarily with a global focus.

For More Information Mail to : info@makrocare.com

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Webinar on Focusing Investigational Sites Risks in RBM


Sponsor’s performance of investigational site risk assessment is essential for effective planning and implementation of clinical trial project. Risk identification starts at the sponsor/CRO system and project level, and also risks are assessed and controlled at site level at pre-study and during the trial. The monitoring approach and content of the study monitoring plan must be based on this risk identification and assessment. This webinar will review site risk identification, assessment steps and how to integrate them into site qualification and into the study monitoring plan. This webinar will also focus on how to coordinate the sponsor quality systems to support risk-based approaches for monitoring and oversight.


  • Identify key investigational site risk categories per project and integration into site qualification and monitoring plan development
  • Recognize risk management factors to coordinate for investigational site oversight: risk assessment, tracking and controlling
  • Importance of centralized monitoring in monitoring investigational site risks
  • Role & responsibilities of central monitor in tracking and managing investigational site risks

Date/ Time: Tuesday, 5th April 2016  I  11 AM – 12 Noon EST


Sandra ‘Sam’ Sather, MS, BSN, CCRA, CCRC, Clinical Operations & Risk Expert
Ashok Ghone,
PhD, VP, Global Services, MakroCare



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RAPS & MakroCare invite you for an evening of learning & networking

Regulatory Intellegence

RAPS & MakroCare is organizing a Seminar on Regulatory Intelligence at Ardmore, PA, USA.The Reg Intelprovides updated regulatory data from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details. The speaker of the Seminar is Alexis Miller, Sr. Director Regulatory Policy & Intelligence and Regulatory Affairs, Eisai, Inc.

At the RAPS Philadelphia chapter, MakroCare is sponsoring a Seminar on “Regulatory Intelligence – It’s Not Just a Buzz Word Anymore”

What will you take with you:

– How the Global Regulatory landscape is changing constantly
– What is RI, how important it is to keep abreast of worldwide regulatory information in today’s world
– What impact RI has on shaping Regulatory Policy
– Where one can find RI and how reliable is that info
– How to leverage RI tools

About Speaker:

Alexis Reisin Miller is Senior Director, Regulatory Policy and Intelligence at Eisai Inc.  Alexis is a member of Eisai’s Global Regulatory Affairs unit, and works with the Public Policy, Development, Commercial, Government Affairs, Legal, and other departments on a variety of regulatory and policy matters ranging from premarket(product creation and development) through commercialization. Through the commenting process, presenting and attending conferences, participating in working groups, and other outreach activities (e.g., working with industry organizations, FDA, and external colleagues), Alexis contributes to regulatory policy dialogue as it evolves, with the ultimate goal of helping to shape the regulatory environment.

Agenda of the Evening:
5:30 -6:00 pm – Welcome and Networking, Speaker Introduction
6:00- 7:00 pm – Presentation and Questions
7:00 to 8:30 pm – Open table discussions, Networking

Date/Time: 10 December 2015 I 5:30–8:30 pm EST
Venue: Primavera Pizza Kitchen, Ardmore, PA
Speaker: Alexis Miller
Sr. Director, Global Regulatory Policy & Intelligence
Global Regulatory Affairs, Eisai, Inc.

Click on the URL to Register:  https://www.raps.org/EventDetails.aspx?ProductId=76806133

MakroCare’s VISTAAR, global regulatory intelligence specially is designed for Regulatory (Strategy, Policy, Operations, Submissions) teams in BioPharma and Medical device companies. It provides updated regulatory data from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details.

VISTAAR will keep life science professionals up to date with the constantly changing/evolving regulatory environment with an easy access to continuously updated accurate drug regulatory information.

In addition, custom research projects on regulatory intelligence are also handled by VISTAAR’s experienced team.

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Webinar on eTMF – Challenges, Opportunities & Trends


Essential Documents are the evidence that demonstrate Investigators, Sponsors, and Monitors have met the expectations of Good Clinical Practices (GCPs) and related regulations. The documentation stored in the Trial Master File is becoming increasingly digitized driving eTMF adoption across the industry. The trends in industry best practices, regulations and technology will change the models of today and the associated business processes. The careful planning and astute attention to the environment will ensure awareness and timely decision making. It is evident that the changing landscape of partnerships, outsourcing, regulations and guidelines will affect the roles and responsibilities of stakeholders including authors, reviewers and users of eTMF.

This webinar will examine the impact these changes would bring to document management using eTMF. The Sponsor/CRO, Monitors and Investigator/Site roles will be assessed for opportunities in the transition to eTMF trends. Attention will be paid to the anticipated evolution of industry best practices, regulatory guidance and the underlying technology innovations. The action plans will be outlined to optimize changes to eTMF implementation & management processes while ensuring efficiency and compliance. The change management proposals to encourage endorsement and adoption will be discussed.

The webinar will –

  • Describe the potential of eTMF for impact on the business processes currently utilized by regulators, researchers and patients
  • Recognize the benefit and challenges, anticipated eTMF trends would bring to business processes
  • Identify the opportunities future trends may facilitate for increased compliance and patient safety

Date & Time: Thursday,  10th Dec at 11 AM EST.

Cost : None

Speaker: Ms. Betsy Fallen

About Betsy Fallen: Ms. Betsy Fallen an expert in TMF metrics and MCC Risk-Based Monitoring initiatives. She has proficiency in regulatory and clinical operations, data management, and ancillary supply chains, among other areas.

Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives and SIACs, including the TMF Reference Model, Chair of the SAFE-BioPharma Global Business and Regulatory Group, PhRMA Electronic Regulatory Submissions Working Group, NCI caBIG CRIX and the IRISS Steering Committee Chair.

Currently, Betsy is an independent consultant providing expertise to industry and an active member of DIA.

Contact: For more information mailto: webinar@makrocare.com

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Webinar on Regulatory Outsourcing: ” To or Not To”

Regulatory Outsourcing To or Not To

To Outsource or Not to Outsource”, the question that many of the companies may be asking.

The webinar aims to compare and contrast the advantages & disadvantages of conducting Regulatory Affairs from both a Sponsor/Manufacturers’ Point of View and from a RA Vendor’s Perspective.

Some of the Topics Covered are:

Should you consider outsourcing or not
What to Outsource & what not to
Hybrid Models
Share Practical Experiences

Date & Time :

Date: Wednesday, 26th August 2015

Time: 4 – 5 PM CET | 11 AM – 12 PM EST

Cost : None

Speakers: Dr. Alan A. Chalmers

About Speaker:

Dr Alan A. Chalmers is a pharmacist with over 35 years’ industrial experience mainly in the field of pharmaceutical regulatory affairs.

A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialization in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation.
After a few years 1975-1978 as Pharmaceutical Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group), he joined Ciba-Geigy in DRA in 1978. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs with global regulatory responsibilities for both new products and product maintenance.

Dr. Chalmers has been a consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organizing Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.

For more information mailto: webinar@makrocare.com

About MakroCare:

It’s a journey of 15 years with clients from across the Globe providing a broad range of knowledge-based contract research and consulting services to the worldwide pharmaceutical, biotechnology, and medical device industries. MakroCare has successfully helped clients launch products or expand into newer regions. Services included Regulatory Strategy to getting product approvals globally to maintain compliance. By effectively “productizing” knowledge and experience in the form of Regulatory Affairs Center of Excellence (RACoE), MakroCare has helped clients either accelerate their projects or save costs. MakroCare has developed Multi-Dimensional Regulatory Service Accelerators (NAVAT) that is helping companies to accelerate their Global Submissions and receive faster Approvals. In addition, our functional services include CMC Authoring, global submission management, LCM, Labeling & affiliate support.

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Webinar on Unique Device Identification (UDI): What and How within overall Medical Device Value Chain.

Free Webinar on Unique Device Identification (UDI) – June 18th 2015.

Planning and Implementation of the Medical Device Regulation (UDI)

Step 1. Developing the UDI compliance plan

  • Brief senior management on project scope and provide resource requirements with cost
  • Receive senior management project approval
  • Build the right team members who are dedicated and have the right complement of product/process knowledge
  • Define clear roles, accountabilities and responsibilities
  • Understand the requirements of the Medical Device Regulation
  • Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan
  • Evaluate the supply chain business processes
  • Produce gap assessment and generate gap findings and conclusions
  • Prepare for innovative and sustainable change to the go-forward environment – monitor publications
  • Plan and provide that product experts enable knowledge transfer
  • Develop a plan for Change Management

Step 2. Understanding the Machine Readable Technology

  • That number on the medical device, It’s not just a number….It means something
  • Standard product identifier
  • Reach out to the global community
  • Benefit to the medical community
  • Better traceability
  • Expedite recalls

Step 3. Change Management

  • Create compelling story or business case
  • Build a team who are fully committed to the change initiative
  • Create the vision
  • Communication, Communication, Communication
  • Start with “short term” wins

Step 4. Risk Assessment keeping the system agile for future changes

  • Proactively identify and manage risks
  • Assess Labeling changes – Global Packaging
  • Supply Chain continuity planning

Step 5. Implementation of UDI plan across the value chain

  • Review with project team key points of requirement
  • Identify the representative products for assessments
  • Build implementation road map, resourcing including cost
  • Identify low impact product device for implementation as pilot project
  • Present implementation recommendations and validate with stakeholders
  • Parallel process low impact product device
  • Evaluate and communicate results of “pilot” product

Step 6. Identifying the data sources for FDA reporting

  • Develop UDI data source map
  • Develop UDI database for FDA Reporting
  • Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)

Register your seat at this webinar for FREE!

Who should participate?

* Compliance Quality Assurance
* Risk Management professionals
* Regulatory affairs professionals
* Exe. Mgmt. Business Owners
* Labeling professionals
* Post Market professionals
* Safety professionals
* International BD professionals
* Medical Device Manufacturers

Speaker: Jim Petragnani

Jim developed multiple solutions and systems while directing the business development function at GS1, and implemented technology, standards and systems around framework similar to UDI, for various industries like Defense, Aviation including Medtech. He was also instrumental in consulting Industry members to assist FDA in developing the UDI framework and regulation. Jim Brings extensive experience and understanding on information technology and supply chain systems development and implementation.

Limited Participants:
Maximum 100 only

Send your information for registration to mailto: webinar@makrocare.com

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