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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Medical Device Pathway in India

Medical device market in India.

India is one of the largest medical device markets in Asia and it is growing significantly. Medical device market in India is pegged at $6.3 billion in 2013 and growing annually at 10-12 percent. Most of it is dominated by imported products. According to a recent report by The Boston Consulting Group (BCG), around 70 per cent of the medical devices used in India are imported.

As per the risk-based classification of medical devices, Low risk devices to be marketed with self-certification and High risk devices to be marketed after obtaining conformity assessment. Currently, manufacturers of medical devices which require registration in India should supply evidence of marketing authorization in the US, Canada, Europe, Australia or Japan, plus proof of approval in their country of origin. Full technical documentation must be submitted for CDSCO approval. Additionally, each manufacturing facility must be registered.

MakroCare takes pleasure in presenting this Webinar. A better understanding of what are DCGI expectations for Medical Device entry, Pathway in India, Medical Device Design & Quality standards, Import License and requirements for medical device clinical trials, product registration and product life cycle management.

Key Topics:

  • Medical Device Market
  • Indian Regulation & Entry pathway
  • Medical device Classification in India
  • Product Registration & Import Requirements
  • Regulatory Timelines
  • Clinical Trial of Medical Devices in India

Register your seat at this webinar for FREE!

Who should participate?
Regulatory Professionals, Clinical Development teams, Clinical Operations, Medical Affairs, Medical device Manufacturers, Clinical Investigators, Clinical Monitors/CRAs, Project Managers and QA Professionals

Limited Participants:
Maximum 75 only


Ms. Parul Chansoria
Biomedical Engineer & RAC






Laxman Jakkala, PhD
Director QA&RA, MakroCare





Date & Time :

Date: Wednesday, 10th December 2014

Time: 3:00 PM CET to 4:30 PM CET

Cost : None

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

For More Information Click Here

Posted in Clinical Development, Clinical Monitors/CRAs, Clinical Operations, Clinical Research - CPC & BPO, Medical Affairs - Scientific, Medical Device, Project Managers, QA Professionals, Regulatory Affairs, Regulatory Compliance, Regulatory Professionals, Regulatory Strategy, Regulatory Submissions, Regulatory Writing | Leave a comment

Webinar on Centralized Monitoring: A Smart & Cost Efficient Clinical Monitoring Approach (Part-II) : 6th October 2014; 11.00 – 12.00 hrs US EST

Pharmaceutical Regulatory Affairs

Part II: Practical Guidance on Adopting Centralized Monitoring Approach

Centralized Monitoring appears to be the most suitable approach available today to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner. The right implementation of a centralized monitoring approach is essential in maximizing benefits with regard to higher quality of study conduct, reporting and better monitoring of patient safety with reduced number of on-site monitoring visits. The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place. Designing realistic, efficient monitoring plans with pre-defined risk indicators, thresholds with suggested action plan, training of resources, selection and validation of analytical tools are important aspects of adopting centralized monitoring.

After overwhelming response to the first webinar on Centralized Monitoring: Understanding process and concept, MakroCare takes pleasure in presenting Part II of this webinar. As the industry is moving forward with the process of standardization and optimization for centralized monitoring to create further efficiencies in clinical trial management and to enhance data quality, this webinar will provide further insight in adopting a successful Centralized Monitoring approach.

  • Monitoring plans encompassing centralised monitoring
  • Technology to support a centralised monitoring approach
  • Real case scenario on reporting of centralised monitoring activities
  • Guidance on the aspects of system validation necessary for effective centralised monitoring


Sue Fitzpatrick
Director of Redtree People and Independent Training Consultant
Former Head of Education and Training
The Institute of Clinical Research, UK


Jane Tucker
Independent Risk Management Consultant and Trainer, UK


Speaker & Facilitator

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA


 Date & Time :

Date: Monday, 6th October 2014

Time: 11.00 – 12.00 hrs US EST / 16.00 -17.00 hrs UK (BST)

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

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